Metformin Therapy in Type 1 Diabetes Mellitus.
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|ClinicalTrials.gov Identifier: NCT01889706|
Recruitment Status : Unknown
Verified June 2013 by Agnieszka Zawada, Poznan University of Medical Sciences.
Recruitment status was: Recruiting
First Posted : June 28, 2013
Last Update Posted : June 28, 2013
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.
|Condition or disease|
|Loss of Control of Diabetes|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Application of Metformin as Adjuvant Therapy in Overweight and Obese Patients With Type 1 Diabetes Mellitus.|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||February 2014|
- Body fat content and anthropometric parameters [ Time Frame: 6 months ]assessed by electrical bioimpedance using a Tanita BC-418 MA device,
- Assessment of metabolic control [ Time Frame: 6 months ](HbA1C, lipid profile)
- Insulin requirement [ Time Frame: 3 , 6 months ]
- Assessment of skin AGE [ Time Frame: 6 months ]AGE-Reader ( Diagn-Optic)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889706
|Department of Internal Medicine and Diabetology, Raszeja Hospital||Recruiting|
|Poznan, Great Poland, Poland, 60-834|
|Contact: Agnieszka Zawada, MD firstname.lastname@example.org|
|Principal Investigator:||Dariusz Naskręt, PhD||Poznań University of Medical Sciences|