Metformin in Obese Children with Abnormal Glucose and Insulin Status

Completed

• Conditions: utritional, Metabolic, Endocrine: Obesity; Nutritional, Metabolic, Endocrine; Obesity

• Registration Number: ISRCTN19517475
• Lead Sponsor: Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-29
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

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 <11.1 (+/- impaired fasting glucose > or = 6.1 to < 7)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified