Prevention of Diabetes Mellitus Development in Women Who Had Already Experienced A Gestational Diabetes

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

Gestational diabetes is also a strong risk factor for the development of diabetes mellitus at a later stage of life in previous GDM woman. Among all the risk factors of diabetes mellitus, the experience of gestational diabetes is the strongest one. The incidence of various forms of diabetes in this group balances from 10 to 60% over a period from 2 to 10 years.

The aim of this study is a comparison of the efficacy of life style modification and life style modification in conjunction with metformin administration, in a population of women, who had already experienced gestational diabetes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Lodz; Medical Universtity of Lodz
• Treatments: Metformin

Criteria

Inclusion Criteria:

• GDM - experienced during pregnancy (diagnosis of GDM according to WHO-criteria)

• Breast-feeding of the newborn finished (lactation finished)

• Actual BMI >= 25 kg/ m2

• Written consent for participation in the study

• A hitherto prevailing good cooperation with the patient

Exclusion Criteria:

• Cholestasis during the past pregnancy

• Any hepatic diseases in the past (viral hepatitis, toxic hepatic damage,jaundice of unknown etiology)

• Serum ASPAT and/or ALAT level exceeding more than twice normal laboratory values

• Pregnancy planned during the coming two years

• Presence of contradictions for metformin administration according to demands of the Drug Admission Committee in Poland