Diabetes, Endocrine, Metabolic and Nutritional
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Does insulin resistance influence neurodegeneration in non-diabetic Alzheimer's subjects?BackgroundType 2 diabetes is a risk factor for Alzheimer's disease (AD), and AD brain shows impaired insulin signalling. The role of peripheral insulin resistance on AD aetiopathogenesis in non-diabetic patients is still debated. Here we evaluated the influence of insulin resistance on brain glucose metabolism, grey matter volume and white matter lesions (WMLs) in non-diabetic AD subjects.MethodsIn total, 130 non-diabetic AD subjects underwent MRI and [18F]FDG PET scans with arterial cannula insertion for radioactivity measurement. T1 Volumetric and FLAIR sequences were acquired on a 3-T MRI scanner. These subjects also had measurement of glucose and insulin levels after a 4-h fast on the same day of the scan. Insulin resistance was calculated by the updated homeostatic model assessment (HOMA2). For [18F]FDG analysis, cerebral glucose metabolic rate (rCMRGlc) parametric images were generated using spectral analysis with arterial plasma input function.ResultsIn this non-diabetic AD population, HOMA2 was negatively associated with hippocampal rCMRGlc, along with total grey matter volumes. No significant correlation was observed between HOMA2, hippocampal volume and WMLs.ConclusionsIn non-diabetic AD, peripheral insulin resistance is independently associated with reduced hippocampal glucose metabolism and with lower grey matter volume, suggesting that peripheral insulin resistance might influence AD pathology by its action on cerebral glucose metabolism and on neurodegeneration.
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Diabetic foot osteomyelitis treatment: An audit of success rates in differing circumstancesOsteomyelitis is a common complication of diabetic foot infection and is associated with a high burden of morbidity and mortality. The success rates of treatment for diabetic foot osteomyelitis treated both surgically and conservatively with antibiotics are widely documented. This study aimed primarily to establish clinical outcomes for people treated with intravenous antibiotics for diabetic foot osteomyelitis at an acute hospital in the UK.
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Insulin resistance influences hippocampal glucose metabolism rather than hippocampal volume in non-diabetic Alzheimer disease patientsBackground: Type 2 diabetes is a risk factor for Alzheimer disease (AD) and it has been demonstated that AD brain shows impaired insulin signalling. Progressive brain hypometabolism is a hallmark of AD and can be evaluated using [18F]-fluorodeoxyglucose (FDG) positron emission tomography (PET). Medial temporal lobe atrophy evaluated on magnetic resonance imaging (MRI) is also a marker of neurodegeneration in AD. Peripheral insulin resistance (IR) may contribute to the etiopathogenesis of AD. Here we evaluated the association between IR, brain glucose metabolism and hippocampal volume in non-diabetic AD subjects. Method(s): 121 AD subjects form the Evaluating Liraglutide in Alzheimer's Disease (ELAD) trial (NCT01843075) were enrolled. Glucose and insulin levels were measured after a 4-hour fast on the day of the visit for the brain MRI and FDG-PET scan. Insulin resistance was calculated by the homeostatic model assessment (HOMA-IR). For [18F]FDG analysis, rCMRGlc parametric images were generated using spectral analysis with an arterial plasma input function. T1 volumetric MRI were acquired on 3T scans and automated hippocampal segmentation was done using FreeSurfer. Result(s): In this non-diabetic AD population, the prevalence of IR was about 16%. HOMA-IR was negatively correlated with the hippocampal rCMRGlc (Spearman's rho= -.232, p=.04). The correlation remained significant after correcting for age. Subjects above the cut-off value for IR (2.9) showed significant lower rCMRGlc in the hippocampus, medial temporal lobe and precentral gyrus compared to those below the cut-off. No significant correlation was observed between HOMA-IR and hippocampal volume. Conclusion(s): In this study in a non-diabetic AD population, peripheral insulin resistance correlates with reduced hippocampal glucose metabolism but not with hippocampal volume. This suggests that the peripheral insulin resistance influence AD pathology by its action on cerebral glucose metabolism and central insulin resistance. Copyright © 2019
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Does insulin resistance influence white matter lesions in non-diabetic AD subjects?Background: Vascular risk factors like hypertension, hyperlipidemia and diabetes mellitus are risk factors for Alzheimer's disease (AD). White matter lesions (WMLs) have been recognized as the imaging characteristics of cerebral small vessel diseases. WMLs are a risk factor for stroke, cognitive decline, and dementia and their prevalence increases with age. In magnetic resonance imaging (MRI), white matter hypointensities in T1-weighted images, and white matter hyperintensities in T2-weighted and FLAIR images are regarded as visualizations of WMLs. Peripheral insulin resistance (IR) may contribute to the etiopathogenesis of AD. Here we evaluated whether insulin resistance exerts its effects on non-diabetic AD subjects by influencing WMLs. Method(s): 121 AD subjects form the Evaluating Liraglutide in Alzheimer's Disease (ELAD) trial (NCT01843075) were enrolled. Glucose and insulin levels were measured after a 4-hour fast on the day of the visit for the brain MRI. Insulin resistance was calculated by the homeostatic model assessment (HOMA-IR). Hypointensity volumetrics determined as WMLs were estimated using the FreeSurfer analysis (http://surfer.nmr.mgh.harvard.edu/) on T1 MRI acquired on 3T scans. Glucose metabolism (rCMRGlc) was calculated by parametric images generated using spectral analysis with an arterial plasma input function. Result(s): In this non-diabetic AD population, the prevalence of IR was about 16%. WMLs volume was not correlated to HOMA-IR. However, WMLs was negatively correlated with left hippocampal volume (Spearman's rho=-.208, p=.02). WMLs volume was positively correlated with age and with serum triglyceride levels and negatively correlated with serum HDL cholesterol levels. Conclusion(s): In this study in a non-diabetic AD population, white matter lesions were not correlated with peripheral insulin resistance. This suggests that in non-diabetic AD subjects, vascular changes are not influenced by peripheral insulin resistance. Copyright © 2019 RN - 50-99-7 (glucose); 84778-64-3 (glucose); 204656-20-2 (liraglutide)
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What is podiatric surgery, and can it help to improve outcomes for chronic diabetic foot disease?The relentless demand for diabetic foot care and the drive to reduce amputation rates is placing an untenable strain on an already financially stretched English national health service. As a consequence, commissioners and providers alike are having to come together to consider novel ways of working. This article argues that integrating podiatric surgery into the acute diabetes multidisciplinary team (MDT) may be part of the solution to easing pressure on hospital services. The authors share their experience of utilising podiatric surgery in the management of diabetic foot disease. Podiatric surgeons in England currently work in a variety of acute and community settings but increasingly have a role to play in the acute MDT. Podiatric surgeons can offer the MDT advice or treatment where the usual conservative podiatric or medical treatments have failed to heal ulceration or infection.
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Variations in the referral of people with diabetic foot ulceration for specialist management: are we missing something?For over three decades, there has been growing evidence that the delayed referral of people with diabetes and foot ulceration to specialist multidisciplinary teams (MDTs) for the management of this condition negatively impacts on its outcomes (MacFarlane and Jeffcoate, 1997; Prompers, 2008; National Diabetes Footcare Audit, 2019). There are continuing calls for this issue to be addressed by way of the implementation of educational strategies (Garcia-Klepzig et al, 2018), refining referral pathways (Meloni et al, 2019) and simplified access to facilities offering specialist MDT care (Barker, 2015). However, extant studies often lack full explanations as to why referral timeframes vary at international, national and individual referrer levels. One reason for this may be the absence of in-depth qualitative data obtained from the multiple healthcare professionals to whom people first present with this condition. This pilot study highlights the need to consider perspectives of referrers when attempting to explain differences in referral timeframes across differing healthcare contexts.
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Comorbid depression and risk of cardiac events and cardiac mortality in people with diabetes: A systematic review and meta-analysisOBJECTIVETo examine the association of comorbid occurrence of diabetes and depression with risk of cardiovascular endpoints including cardiovascular mortality, coronary heart disease and stroke.RESEARCH DESIGN AND METHODSA systematic review and metaanalysis. We searched PUBMED/MEDLINE, Medscape, Cochrane Library, CINAHL, EMBASE and Scopus databases assessing cardiac events and mortality associated with depression in diabetes up until 1 December 2018. Pooled hazard ratios were calculated using random- effects models.RESULTSNine studies met the inclusion criteria. The combined pooled hazard ratios showed a significant association of cardiac events in people with depression and type 2 diabetes, compared to those with type 2 diabetes alone. For cardiovascular mortality the pooled hazard ratio was 1.48 (95% CI: 1.185, 1.845), p=0.001, for coronary heart disease 1.37 (1.165, 1.605), p<0.001 and for stroke 1.33 (1.291, 1.369), p<0.001. Heterogeneity was high in the meta-analysis for stroke events (I-squared = 84.7%) but was lower for coronary heart disease and cardiovascular mortality (15% and 43.4% respectively). Meta-regression analyses showed that depression was not significantly associated with the study level covariates mean age, duration of diabetes, length of follow-up, BMI, sex and ethnicity (p<0.05 for all models). Only three studies were found that examined the association of depression in type 1 diabetes, there was a high degree of heterogeneity and data synthesis was not conducted for these studies.CONCLUSIONSWe have demonstrated a 47.9% increase in cardiovascular mortality, 36.8% increase in coronary heart disease and 32.9% increase in stroke in people with diabetes and comorbid depression. The presence of depression in a person with diabetes should trigger the consideration of evidence-based therapies for cardiovascular disease prevention irrespective of the baseline risk of cardiovascular disease or duration of diabetes.
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The effect of structured group education on HbA1c levels in patients with Type 2 diabetesAims/objectives: To determine the effectiveness of structured group education as per Diabetes Education Self-Management for Ongoing and Newly Diagnosed (DESMOND) national standards on HbA1c levels in patients with Type 2 diabetes. Method(s): Records from a National Health Service (NHS) patient database of 1,123 adults (55.2% male; mean age = 62 years) with Type 2 diabetes were examined between 1 April 2016 and 31 July 2018. Data collected included both newly diagnosed (diagnosis <12 months) and foundation (diagnosis >12 months) patients. HbA1c blood results for the cohort were collected at baseline, six and 12 months post-completion of education. Changes in HbA1c levels were analysed for statistical significance using two-sided paired t-tests. Result(s): At baseline, six months and 12 months, blood results had averages (median) of 58, 50 and 53mmol/mol of HbA1c respectively. HbA1c levels were significantly reduced after six months and 12 months by mean differences of-10.9mmol/mol (+/-1.3; p < 0.0001; n = 878), and-8.4mmol/mol (+/-1.4; p < 0.0001; n = 645) respectively. Conclusions/summary: Our data suggests that the DESMOND education course significantly reduces HbA1c levels over time and is therefore beneficial for sustained self-management of Type 2 diabetes.
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SKIP (Supporting Kids with diabetes In Physical activity): Feasibility of a randomised controlled trial of a digital intervention for 9-12 year olds with type 1 diabetes mellitusBACKGROUND: Physical activity and self-monitoring are important for children with type 1 diabetes mellitus (T1DM) but it is unclear whether interventions delivered online are feasible, acceptable to patients and efficacious. The aim was to assess the feasibility and acceptability of an internet-based physical activity and self-monitoring programme for children with T1DM, and of a randomised controlled trial (RCT) to evaluate efficacy. METHODS: A total of 49 children aged 9-12 with T1DM were randomly assigned to usual care only or to an interactive intervention group combining a website (STAK-D) and a PolarActive activity watch (PAW; Polar Electro (UK) Ltd.), alongside usual care. Participants completed self-report measures on their health, self-efficacy and physical activity at baseline (T0), eight weeks (T1) and six months (T2). They also wore a PAW to measure physical activity for one week at the end of T0, T1 and T2. Intervention participants were interviewed about their experiences at T2. Explanatory variables were examined using multi-level modelling and examination of change scores, 95% confidence intervals and p-values with alpha set at 0.95. Descriptive analysis was undertaken of the 'end-of-study questionnaire'. Qualitative analysis followed a framework approach. RESULTS: Completion rates for all self-report items and objective physical activity data were above 85% for the majority of measures. HbA1c data was obtained for 100% of participants, although complete clinical data was available for 63.3% to 63.5% of participants at each data collection time-point. Recruitment and data collection processes were reported to be acceptable to participants and healthcare professionals. Self-reported sedentary behaviour (-2.28, p=0.04, 95% CI=-4.40, -0.16; p = 0.04; dppc2 = 0.72) and parent-reported physical health of the child (6.15, p=0.01, 95%CI=1.75, 10.55; p = 0.01; dppc2 = 0.75) improved at eight weeks in the intervention group. CONCLUSIONS: The trial design was feasible and acceptable to participants and healthcare providers. Intervention engagement was low and technical challenges were evident in both online and activity watch elements, although enjoyment was high among users. Reported outcome improvements were observed at 8 weeks but were not sustained. TRIAL REGISTRATION: ISRCTN 48994721 (prospectively registered). Date of registration: 28.09.2016.
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Endocrinology of transgender medicineGender affirming treatment for transgender people requires a multidisciplinary approach in which endocrinologists play a crucial role. The aim of this paper is to review recent data on hormonal treatment of this population and its effect on physical, psychological and mental health. The Endocrine Society guidelines for transgender women include estrogens in combination with androgen lowering medications. Feminizing treatment with estrogens and anti-androgens has desired physical changes, such as enhanced breast growth, reduction of facial and body hair growth and fat redistribution in a female pattern. Possible side effects should be discussed with patients, particularly those at risk of venous thromboembolism. The Endocrine Society guidelines for transgender men include testosterone therapy for virilization with deepening of the voice, cessation of menses plus increase of muscle mass, facial and body hair. Due to the lack of evidence, treatment for gender non-binary people should be individualized. Young people may receive pubertal suspension, consisting of gonadotrophin-releasing hormone analogs, later followed by sex steroids. Options for fertility preservation should be discussed before any hormonal intervention. Morbidity and cardiovascular risk with cross-sex hormones is unchanged among transgender men and unclear among transgender women. Sex steroid-related malignancies can occur, but are rare. Mental health problems such as depression and anxiety have been found to reduce considerably following hormonal treatment. Future studies should aim to explore the long-term outcome of hormonal treatment in transgender people and provide evidence as to effect of gender affirming treatment in the non-binary population.
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Screening for metabolic syndrome in patients on antipsychotic medication - A cross-sectional study in a Pakistani sampleMetabolic syndrome includes a number of cardiovascular risk factors that increase morbidity and mortality. Studies have identified increase in incidence of metabolic syndrome in patients with severe mental illness. Atypical antipsychotic medications have been linked with increased risk of metabolic syndrome. Method: 50 consecutive patients who were on antipsychotic medication for 3 months or more were screened for metabolic syndrome using a brief questionnaire, measurement of waist circumference or Body Mass Index and blood pressure and a subsequent blood test for fasting glucose and lipid profile. The anonymised data was analysed and presence of metabolic syndrome was identified using the consensus criteria by WHO, International Diabetic Federation and US National Cholesterol Education Program Adult Treatment Panel III. Results: 96% of the study population were taking second generation antipsychotic medication and for more than 12 months. 30% of the patients were obese and had BMI above 30Kg/m2. 18% of the total sample had elevated BP at or above 135/85 mmHg. 16 % of the patients had elevated Fasting Plasma Glucose Levels above 100mg/dl. 62% of the patients had dyslipidemia. Although 62% of the study sample had at least one individual cardiovascular risk factor (elevated triglyceride level) and 30% had two risk factors (obesity and dyslipidemia), applying the consensus criteria for presence of metabolic syndrome and using cut-off of 3 out of 5 criteria, only 14% of the sample were categorised as having metabolic syndrome. Conclusion: Patients taking antipsychotic medication long-term are at significant risk of metabolic syndrome. A careful risk-benefit analysis should inform the initial choice of antipsychotic medication. Psychiatrists should educate patients about the illness as well as medication related side effects and promote healthy lifestyle practices. Patients should be screened at baseline and monitored at regular intervals throughout the treatment. © 2018 Lahore Medical And Dental College. All rights reserved.
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A physical activity intervention for children with type 1 diabetes- steps to active kids with diabetes (STAK-D): A feasibility studyBACKGROUNDThis study describes the development and feasibility evaluation of a physical activity intervention for children with type 1 diabetes called 'Steps to Active Kids with Diabetes' (STAK-D). It aims to explore the feasibility and acceptability of the intervention and study design.METHODSThirteen children aged 9-11 years and their parents were recruited from one paediatric diabetes clinic. A process evaluation was conducted alongside a two-arm randomised feasibility trial, including assessment of rate of recruitment, adherence, retention, data completion and burden, implementation fidelity and adverse events. Qualitative interviews with children (n = 9), parents (n = 8), healthcare professionals (n = 3) and STAK-D volunteers (n = 8) explored intervention acceptability. Interviews were analysed thematically.RESULTSRate of recruitment was 25%, with 77% retention at 3-month follow-up. Study burden was low, data completion was high and the intervention was delivered as per protocol. No serious adverse event was reported. Engagement with intervention materials was generally good, but attendance at group activity sessions was low due to logistical barriers. Interview analysis identified preferred methods of recruitment, motivations for recruitment, barriers and facilitators to adherence, the experience of data collection, experience of the STAK-D programme and its perceived benefits.CONCLUSIONSSTAK-D was feasible and acceptable to children, their parents and healthcare professionals, but group sessions may present logistical issues. Recruitment and retention may be improved with a clinic-wide approach to recruitment.TRIAL REGISTRATIONThis trial was registered on ClinicalTrials.gov: NCT02144337 (16/01/2014).
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Impact of a new foot care intervention programme in two haemodialysis units in Nottingham, UKEach year a significant number of individuals with diabetes undergoing haemodialysis suffer foot conditions that result in a hospital admission or, at worst, amputation of a limb. In light of this, a podiatry service was introduced on two haemodialysis units based on an acute hospital site in Nottingham, UK. The authors reviewed this service to establish whether its implementation had any impact on major and minor amputation rates, bed days, access to and frequency of preventative podiatry care, and patient satisfaction. The review also aimed to assess the cost of providing the service and monitor the level of referrals from the dialysis units to the local diabetic foot multidisciplinary team and other specialisms for foot problems.
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“Having diabetes shouldn’t stop them”: Healthcare professionals’ perceptions of physical activity in children with Type 1 diabetesBackground: Healthcare professionals (HCP) working with children who have Type 1 Diabetes Mellitus (T1DM) have an important role in advising about and supporting the control of blood glucose level in relation to physical activity. Regular physical activity has known benefits for children with T1DM, but children with chronic conditions may face barriers to participation. The perceptions of HCPs were explored in an effort to understand what influences physical activity in children with T1DM and to inform the practice of those working with children who have T1DM. Methods: Semi-structured interviews with 11 HCPs involved in the care of children with T1DM in the UK were conducted. Interviews were recorded, transcribed verbatim and data were analysed using thematic analysis. Results: The factors perceived to influence participation in physical activity are presented as five major themes and eleven sub-themes. Themes included the positive influence of social support, the child’s motivation to be active, the potential for formal organisations such as school and diabetes clinic to support physical activity, the challenges faced by those who have T1DM and the perceived barriers to HCPs fulfilling their role of promoting physical activity. Conclusions: Healthcare professionals recognised their role in helping children with T1DM and their parents to incorporate physical activity into diabetes management and everyday life, but perceived barriers to the successful fulfilment of this role. The findings highlight the potential for clinical and non-clinical supportive systems to be sensitive to these challenges and facilitate children’s regular participation in physical activity.
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"You can't just jump on a bike and go": A qualitative study exploring parents' perceptions of physical activity in children with type 1 diabetesBACKGROUND: Parents of children with Type 1 Diabetes Mellitus (T1DM) have an important role in supporting diabetes management behaviours and helping to maintain their child's healthy lifestyle. Physical activity has known benefits for children with T1DM [Diabet Med 31: 1163-1173], but children with chronic health conditions typically have low levels of physical activity. Research is needed to build an understanding of the experience of physical activity for children with T1DM. The purpose of this study was to understand parents' perceptions of what influences physical activity for children with T1DM and to inform the practice of those working with children who have T1DM. METHODS: Data were collected through semi-structured interviews with 20 parents (18 mothers, 2 fathers) who had a child aged 7 - 13 years with T1DM in the UK. Interviews were recorded, transcribed verbatim and data were analysed using thematic analysis [Qual Res Psychol 3: 77-101, 2006]). RESULTS: Factors believed to influence participation in physical activity are presented as 7 major themes and 15 subthemes. Themes that emerged included the conflict between planning and spontaneous activity, struggles to control blood glucose, recognition of the importance of physical activity, the determination of parents, children relying on their parents to manage physical activity, the importance of a good support system and individual factors about the children that influence physical activity participation. CONCLUSIONS: This study highlights that parents serve as gate-keepers for children's physical activity. The findings provide insight into the need for T1DM knowledge and competence in personnel involved in the supervision of children's physical activities. Healthcare providers should collaborate with families to ensure understanding of how to manage physical activity. The findings sensitise professionals to the issues confronted by children with T1DM and their parents, as well as the methods used by children and their families to overcome obstacles to physical activity. The implications for further research, clinical practice, and physical activity promotion with children with T1DM are discussed.
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Vancomycin-impregnated calcium sulfate treatment for diabetic foot ulcerationCalcium sulfate can be mixed with a broad range of antibiotics for the local treatment of bone or soft-tissue infection, in many cases avoiding the need for prolonged oral or parental antibiotic treatment. Here we present a case of plantar hallux ulceration in a patient with diabetes complicated by a history of osteomyelitis. The combination of antibiotic-impregnated calcium sulfate and a multidisciplinary approach achieved successful resolution of an ulceration that had been present for six years.
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Knowledge and awareness of type 1 diabetes among primary school initial teacher traineesNew guidelines state that all school staff involved in the care of children and young people with diabetes need to receive training to do so. However, trainee teachers are unlikely to receive this education before they have qualified, even though they may have to support these children while on placement. These authors have developed a questionnaire to assess trainee teachers' knowledge of type 1 diabetes and its management. Applying the questionnaire to three cohorts of trainee teachers revealed inadequate knowledge. Education about diabetes should form part of initial teacher training or even part of secondary education. The questionnaire could also be used to evaluate the effects of diabetes training.
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Hypoglycaemia and improved testicular parameters in Sesamum radiatum treated normo-glycaemic adult male Sprague Dawley ratsThe development of a new dietary adjunct with a novel natural antioxidant impact on diabetes mellitus with prevention of its long term deleterious effect on the male fertility in general has been increasingly expressed in recent time. Hence, we aim to evaluate the effects of aqueous extract of Sesame radiatum leaves on adult male Sprague Dawley rats' testis using unbiased stereological, biochemical and hormonal studies. Thirty adult male rats were divided into three groups of 10 rats each. The treated groups; 1 and 2 received 28.0 and 14 mg/kg bwt of aqueous extract of sesame leaves via oral garvage, respectively, while the control group received equal volume of 0.9% ( w/v) normal saline per day for 6 weeks. Serum follicle-stimulating hormone ( FSH), testosterone and blood glucose were assayed. In addition five microns of uniformly random transverse sections of processed testicular tissues were equally analyzed using an un-biased stereological study. The result showed that the mean percentage volume fractions ( Vf) of epithelial cells and lumen of the testis were 76% ( P<0.05) and 22% ( P<0.05), respectively, in the low dose compared to control. Conversely to the Vf of stroma and glucose level in treated, the mean raw weights of testis and of body weights ( g) with the Vf of ST-epithelium in the treated groups were found ( P>0.05) higher than the control in a dose related manner. Serum testosterone and FSH were significantly higher and lower, respectively, in the high dose sesame when compared to control. Sesame leaves intake improved glucose profile and testicular parameters in a dose related manner via possible improved insulin activity on the cells with a stimulatory impact on sperm production. This also confirmed its folkloric claims.
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An exploration of the experiences of young women living with type 1 diabetesThe aim of this research was to explore young women's experience of living with type 1 diabetes. Nine young women aged between 18 and 24 took part in semi-structured interviews. Data were analysed using Interpretive Phenomenological Analysis. Four main super-ordinate themes emerged; ;the relationship with the body', ;personal challenges', ;the impact of relationships' and ;changing and adapting'. These themes provide a deeper understanding of the issues faced by young women with type 1 diabetes. The implications for clinical practice are discussed.;
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Feasibility of an online intervention (STAK-D) to promote physical activity in children with type 1 diabetes: Protocol for a randomised controlled trialRegular physical activity has important health benefits for children with type 1 diabetes mellitus (T1DM), yet children and their parents face barriers to participation such as lack of self-efficacy or concerns around hypoglycaemia. Multimedia interventions are useful for educating children about their health and demonstrate potential to improve children's health-related self-efficacy, but few paediatric clinics offer web-based resources as part of routine care. The Steps to Active Kids with Diabetes (STAK-D) programme is an online intervention grounded in psychological theory (social cognitive theory) and informed by extensive preliminary research. The aim of the programme is to encourage and support safe engagement with physical activity for children with T1DM. The aim of this research is to explore the feasibility of delivering the STAK-D programme to children aged 9-12 years with T1DM, and to assess the feasibility of further research to demonstrate its clinical and cost-effectiveness. Up to 50 children aged 9-12 years with T1DM and their parents will be recruited from two paediatric diabetes clinics in the UK. Child-parent dyads randomised to the intervention group will have access to the intervention website (STAK-D) and a wrist-worn activity monitor for 6 months. The feasibility of intervention and further research will be assessed by rate of recruitment, adherence, retention, data completion and adverse events. Qualitative interviews will be undertaken with a subsample of children and parents (up to 25 dyads) and health care professionals (up to 10). Health outcomes and the feasibility of outcome measurement tools will be assessed. These include self-efficacy (CSAPPA), objective physical activity, self-reported physical activity (PAQ), fear of hypoglycaemia (CHFS; PHFS), glycaemic control (HbA1c), insulin dose, Body Mass Index (BMI), health-related quality of life (CHU9D; CHQ-PF28), health service use and patient-clinician communication. Assessments will be taken at baseline (T0), 8 weeks (T1) and at 6-month follow-up (T2). The goal of this feasibility trial is to assess the delivery of STAK-D to promote physical activity among children with T1DM, and to assess the potential for further, definitive research to demonstrate its effectiveness. Results will provide the information necessary to design a larger randomised controlled trial and maximise the recruitment rate, intervention delivery and trial retention. ISRCTN, ISRCTN48994721 . Registered on 28 October 2016.