Health Condition 1: E109- Type 1 diabetes mellitus without complications
Conditions
Interventions
Sponsors
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
| Measure | Time frame |
|---|---|
| Glycemic control, dose of insulin, lipid profileTimepoint: baseline,3 months, 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Insulin Resistance, Carotid Intima Thickness, Leptin and AdiponectinTimepoint: 0 month and 6 month | — |
Countries
India
Contacts
Hirabai Cowasji Jehangir Medical Research Institute