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

To study the Effect of use of Metformin with insulin in Indian adolescents and young adults with Type 1 Diabetes- A 6 month Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/11/022126
Enrollment
90
Registered
2019-11-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Metformin: less than 30 kgs- oral metformin (500mg) once a day for total of 6 months. 30-60 kgs- oral metformin (500mg) once a day for 15 days and increase to twice a day for total of 6

Sponsors

Hirabai Cowasji Jehangir Medical Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Glycemic control, dose of insulin, lipid profileTimepoint: baseline,3 months, 6 months

Secondary

MeasureTime frame
Insulin Resistance, Carotid Intima Thickness, Leptin and AdiponectinTimepoint: 0 month and 6 month

Countries

India

Contacts

Public ContactDr Ravindra Ghooi

Hirabai Cowasji Jehangir Medical Research Institute

anuradhavkhadilkar@gmail.com09850244305

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 6, 2026