None listed
Conditions
Brief summary
Obesity in adolescents is a major public health problem in Australia and the prevalence is increasing. Along with the rise in prevalence of obesity there has been a dramatic increase in the number of adolescents with insulin resistance and/or pre-diabetes. It is essential that insulin resistance/pre-diabetes in adolescents be targeted for early intervention. Unmanaged it is likely to progress to type 2 diabetes and early cardiovascular disease. Development of type 2 diabetes in adolescence is of particular concern as complications are common and appear early in the disease. However, there is only limited evidence to guide management of clinical insulin resistance in young people. The aim of this study is to establish an evidence based management plan for these adolescents by undertaking a randomised control trial designed to examine the role of dietary protein in improving insulin sensitivity and metabolic profile.
Interventions
All participants (intervention group and comparator group) will be prescribed metformin and participate in a diet and exercise program. The diet and exercise program will be the same for all participants except for the macronutrient content of the diet. The intervention diet is moderate carbohydrate and increased protein. Carbohydrate will provide 40 to 45% of energy and protien will provide 25 to 30% of energy. The energy level will be tailored on an individual basis to incorporate an energy re
All participants (intervention group and comparator group) will be prescribed metformin and participate in a diet and exercise program. The diet and exercise program will be the same for all participants except for the macronutrient content of the diet. The intervention diet is moderate carbohydrate and increased protein. Carbohydrate will provide 40 to 45% of energy and protien will provide 25 to 30% of energy. The energy level will be tailored on an individual basis to incorporate an energy restriction of approximately 500-1000 kilojoules (kJ)/day. Particpants will be encourage to stay on the diet for 12 months.Individual, face to face, dietary instruction will be given by a dietitian (6 consultations of 30 to 60 minutes, over 12 months) which will be supported by computer/phone support (8 contacts of 5 to 10 minutes, over 12 months) according to a pre established schedule
Sponsors
Sarah Garnett
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
Overweight/obese with a fasting insulin (pmol/L)/glucose (mmol/L) ratio >20 and one or more of the following: acanthosis nigricans, polycystic ovarian syndrome (PCOS), hypertension, dyslipidaemia.
Exclusion criteria
Type 1 or type 2 diabetes , contraindications to metformin therapy, secondary causes of obesity, psychiatric disturbance, significant mental illness, inability to take part in physical activity, taking metformin, weight loss medications or medications known to cause weight gain, and weight >120kg. Neither parent nor carer speaks English.
Outcome results
None listed