5 research outputs found
Researching Effective Strategies to Improve Insulin Sensitivity in Children and Teenagers - RESIST. A randomised control trial investigating the effects of two different diets on insulin sensitivity in young people with insulin resistance and/or pre-diabetes.
Researching Effective Strategies to Improve Insulin Sensitivity in Children and Teenagers - RESIST. A randomised control trial investigating the effects of two different diets on insulin sensitivity in young people with insulin resistance and/or pre-diabetes.
Abstract Background Concomitant with the rise in childhood obesity there has been a significant increase in the number of adolescents with clinical features of insulin resistance and prediabetes. Clinical insulin resistance and prediabetes are likely to progress to type 2 diabetes and early atherosclerosis if not targeted for early intervention. There are no efficacy trials of lifestyle intervention in this group to inform clinical practice. The primary aim of this randomised control trial (RCT) is to determine the efficacy and effectiveness of two different structured lifestyle interventions differing in diet composition on insulin sensitivity, in adolescents with clinical insulin resistance and/or prediabetes treated with metformin. Methods/design This study protocol describes the design of an ongoing RCT. We are recruiting 108 (54 each treatment arm) 10 to 17 year olds with clinical features of insulin resistance and/or prediabetes, through physician referral, into a multi-centred RCT. All participants are prescribed metformin and participate in a diet and exercise program. The lifestyle program is the same for all participants except for diet composition. The diets are a high carbohydrate, low fat diet and a moderate carbohydrate, increased protein diet. The program commences with an intensive 3 month dietary intervention, implemented by trained dietitians, followed by a 3 month intensive gym and home based exercise program, supervised by certified physical trainers. To measure the longer term effectiveness, after the intensive intervention trial participants are managed by either their usual physician or study physician and followed up by the study dietitians for an additional 6 months. The primary outcome measure, change in insulin sensitivity, is measured at 3, 6 and 12 months. Discussion Clinical insulin resistance and prediabetes in the paediatric population are rapidly emerging clinical problems with serious health outcomes. With appropriate management these conditions are potentially reversible or at least their progression can be delayed. This research study is the first trial designed to provide much needed data on the effective dietary management for this cohort. This study will inform clinical practice guidelines for adolescents with clinical insulin resistance and may assist in preventing metabolic complications, type 2 diabetes and early cardiovascular disease. Trial registration Australian and New Zealand Clinical Trials Registration Number ACTRN12608000416392</p
Optimal macronutrient content of the diet for adolescents with prediabetes: RESIST a randomised control trial
CONTEXT: Prediabetes and clinical insulin resistance in adolescents are rapidly emerging clinical problems with serious health outcomes. OBJECTIVE: The objective of this study was to determine the efficacy of 2 structured lifestyle interventions, both differing in diet macronutrient composition, on insulin sensitivity. DESIGN: This study was a randomized controlled trial, known as Researching Effective Strategies to Improve Insulin Sensitivity in Children and Teenagers, in 2 hospitals in Sydney, Australia. PARTICIPANTS: Participants included overweight or obese 10- to 17-year-olds with either prediabetes and/or clinical features of insulin resistance. INTERVENTION: At baseline adolescents were prescribed metformin and randomized to a structured diet, which was either high carbohydrate or moderate carbohydrate with increased protein. The program commenced with a 3-month dietary intervention, with the addition of an exercise intervention in the next 3 months. OUTCOMES: The outcomes included an insulin sensitivity, anthropometry, and cardiometabolic profile at 6 months. RESULTS: One hundred eleven subjects (66 girls) were recruited and 98 subjects (58 girls) completed the 6-month intervention. After 3 months the mean insulin sensitivity index increased by 0.3 [95% confidence interval (CI) 0.2–0.4]. After 6 months the mean insulin (picomoles per liter) to glucose ratio (millimoles per liter) decreased by 7.2 [95%CI −12.0 to −2.3], body mass index, expressed as a percentage of the 95th centile, decreased by 9% (95% CI −3 to −15), but there was no significant change in the lipids. There were no significant differences in outcomes between the diet groups at any time point. CONCLUSIONS: These results are in contrast with our hypothesis that adolescents randomized to the increased protein diet would have better outcomes. Further strategies are required to better address prediabetes and clinical features of insulin resistance in adolescents. AFFILIATIONS Institute of Endocrinology and Diabetes (S.P.G., M.G., J.H., S.S., G.R.A., C.T.C.), The Children's Hospital Institute of Sports Medicine (C.R.B.), and Nutrition and Dietetics, Weight Management Services (S.B., K.C.), and The Centre for Research into Adolescent's Health (M.R.K.), The Children's Hospital at Westmead, The Children's Hospital at Westmead Clinical School (S.P.G., M.G., M.H., L.A.B., G.R.A., C.T.C.), University of Sydney, Westmead, New South Wales 2145, Australia; Commonwealth Scientific and Industrial Research Organisation Food and Nutritional Sciences (M.N.), Adelaide Business Centre, South Australia 5000, Australia; Department of Paediatrics (H.J.W.), Campbelltown Hospital, Campbelltown, New South Wales 2560, Australia; Department of Diabetes and Endocrinology (H.J.W.), Sydney Children's Hospital Network, Randwick, New South Wales 2031, Australia; and Academic Department of Adolescent Medicine (K.S.), Sydney Medical School, University of Sydney, New South Wales 2066, AustraliaSarah P. Garnett, Megan Gow, Mandy Ho, Louise A. Baur, Manny Noakes, Helen J. Woodhead, Carolyn R. Broderick, Susie Burrell, Kerryn Chisholm, Jocelyn Halim, Sukanya De, Katherine Steinbeck, Shubha Srinivasan, Geoffrey R. Ambler, Michael R. Kohn, and Chris T. Cowel