To study the use of metformin with insulin in Indian children with type 1 diabetes

Not Applicable

• Conditions: Health Condition 1: E109- Type 1 diabetes mellitus without complications

• Registration Number: CTRI/2019/11/022126
• Lead Sponsor: Hirabai Cowasji Jehangir Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Confirmed type 1 diabetes (c-peptide, GAD antibodies)

2. Age > 10 years

3. Diabetic duration > 1 year.

4. Lack of metabolic control (HbA1c above 7.5% despite intensive insulin treatment)

Exclusion Criteria

1. Lack of treatment adherence

2. Renal impairment (microalbuminuria), liver disease, hypothyroidism, celiac disease,

hypertension, underweight children

3. Medications affecting insulin sensitivity (oral steroids, immunosuppressants, noninsulin

antidiabetic agents, atypical antipsychotics), antihypertensive medications

4. Severe illness or diabetic ketoacidosis within 60 days or severe hypoglycemic episode in 6

months prior to recruitment, more than two episodes of diabetes ketoacidosis in the

previous 12 months

5. Inability to tolerate metformin

6. Plans to alter amount of exercise, mode of insulin delivery, or diet during the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycemic control, dose of insulin, lipid profileTimepoint: baseline,3 months, 6 months

Secondary Outcome Measures

Name	Time	Method
Insulin Resistance, Carotid Intima Thickness, Leptin and AdiponectinTimepoint: 0 month and 6 month