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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by Medical Universtity of Lodz.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT00265746
First received: December 14, 2005
Last updated: February 27, 2006
Last verified: December 2005

December 14, 2005
February 27, 2006
November 2005
Not Provided
Incidence of type 2 diabetes mellitus.
Same as current
Complete list of historical versions of study NCT00265746 on ClinicalTrials.gov Archive Site
Incidence of IGT
Same as current
Not Provided
Not Provided
 
Prevention of Diabetes Mellitus Development in Women Who Had Already Experienced A Gestational Diabetes
Program for the Prevention of Diabetes Mellitus Development in Women Who Had Already Experienced A Gestational Diabetes. Evaluation of the Efficacy of the Life-Style Modification and the Life-Style Modification in Conjunction With Metformin, in the Prevention of Diabetes Mellitus Development in a Population of Women Who Had Expired a Gestational Diabetes - a Multicenter, Randomized, Double Blind Study.

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.

Gestational diabetes mellitus (GDM) is one of the most frequent metabolic disorders occurring during pregnancy that complicates both, the course of pregnancy and the delivery and is also responsible for many fetal complications. 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.

Presently, in the literature, there are described new, more efficient methods of diabetes prevention in groups with a high risk of this disorder, which involve both, a modification of the life style and pharmacotherapy. The use of metformin in patients with a impaired glucose tolerance, resulted in a ca. 30% reduction of the diabetes incidence rate.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Type 2 Diabetes Mellitus
  • Drug: Metformin
  • Behavioral: Lifestyle intervention - diet, physical activity
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
Not Provided
Not Provided

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
Female
18 Years to 50 Years
No
Contact: Katarzyna Cypryk, MD, PhD, Habilitation 0048422711159 kcypryk@mp.pl
Poland
 
NCT00265746
KBN Nr 2 P05001 28
Not Provided
Not Provided
Medical Universtity of Lodz
Not Provided
Principal Investigator: Katarzyna Cypryk, MD , PhD, Habilitation Medical University in Lodz
Medical Universtity of Lodz
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP