NCT01889706

Metformin Therapy in Type 1 Diabetes Mellitus.

Application of Metformin as Adjuvant Therapy in Overweight and Obese Patients With Type 1 Diabetes Mellitus.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Poznan University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The use of exogenous insulin and incorrect nutritional habits are conducive to obesity and excess weight. This leads to the development of insulin resistance, even in patients with type 1 diabetes mellitus. The purpose of this study is to assess the effects of metformin as adjunctive therapy on anthropometric parameters, insulin resistance and metabolic control in overweight and obese patients with type 1 diabetes mellitus. The study group consists of 200 Caucasian type 1 diabetic patients with elevated adipose tissue content as measured by electrical bioimpedance, treated at the Poznan University of Medical Sciences Department of Diabetology in 2009-2014. All patients have type 1 diabetes diagnosed by autoimmune antibodies, and are treated with intensive insulin therapy. This group is divided into metformin treated arm (group I+ M, 100 subjects), the remaining 100 patients are treated with insulin alone (control group, group I). Metformin is administered at least 6 months at a mean dose of 1000 mg/day. The investigators would like to assess the impact of metformin treatment on metabolic control, insulin resistance and anthropometric parameters in overweight and obese patients with type 1 diabetes.

Conditions

• Loss of Control of Diabetes

Timeline

• Start date: 2009-01-01
• Primary completion: 2013-03-01
• Completion: 2014-02-01
• First posted: 2013-06-28
• Last updated: 2013-06-28

Locations

1 site across 1 country: Poland