Nutritional, Metabolic, Endocrine: Obesity Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
Previous interventions:
1. Metformin (500mg)
2. Placebo
Current interventions as of 15/12/2008:
1. Metformin 1g mane, 500mg nocte
2. Placebo
Sponsors
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Eligibility
Inclusion criteria
Inclusion criteria: Prior to 16 December 2008: 80 patients aged between 9-18 years old As of 16 December 2008: 1. Pubertal and post-pubertal children : Fasting insulin > 26 mIU/l 2. Pre-pubertal children : Fasting insulin > 15 mIU/l 3. 120 minute insulin > 89 mIu/l AND/OR Impaired glucose tolerance ie: OGTT 2hr plasma glucose value > or = 7.8 to or = 6.1 to < 7)
Exclusion criteria
Exclusion criteria: Added 16 December 2008: 1. Glycosuria 2. Ketonuria 3. Other chronic illness or chromosomal abnormality or syndrome eg. Prader-Willi, Turner?s syndrome, hypothyroidism 4. Renal insufficiency 5. Hepatic dysfunction (raised ALT >2 SDS above mean) 6. Chronic diarrhoea 7. Previous episode lactic acidosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in BMI SDS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Added 16 December 2008: fasting and 2 hr insulin and glucose levels on OGTT, measures of insulin resistance, fasting lipids, CRP, adiponectin, leptin, resistin, blood pressure. | — |
Countries
United Kingdom
Outcome results
None listed