Dietary itervention in overweight adolescents with pre-diabetes

Not Applicable

Completed

• Conditions: Pre-diabetes; Clinical insulin resistance; Metabolic and Endocrine - Metabolic disorders

• Registration Number: ACTRN12608000416392
• Lead Sponsor: Sarah Garnett

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
10,000/square root of (fasting insulin (?U/ml) x fasting glucose (mg/dl)) x (mean 2hr insulin (?U/ml) x mean 2hr glucose (mg/dl))[Baseline, 3 months, 6 months, 12 months]

Secondary Outcome Measures

Name	Time	Method
Adiposity. Adiposity will be measured by dual energy x-ray absorptiometry and anthropometry[Baseline, 3 months, 6 months, 12 months];Insulin sensitivity index (OGTT) and adiposity will be measured by dual energy x-ray absorptiometry and anthropometry[24 months]