Text Size

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
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: Metformin
Behavioral: Lifestyle intervention - diet, physical activity
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical Universtity of Lodz:

Primary Outcome Measures:
  • Incidence of type 2 diabetes mellitus.

Secondary Outcome Measures:
  • Incidence of IGT

Estimated Enrollment: 300
Study Start Date: November 2005
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00265746

Contacts
Contact: Katarzyna Cypryk, MD, PhD, Habilitation 0048422711159 kcypryk@mp.pl

Locations
Poland
Department of Endocrinology and Isotope Therapy, Polish Mother’s Memorial Hospital, Research Institute, Lodz Recruiting
Lodz, Poland
Contact: Katarzyna Cypryk, M D, PhD , Habilitation     0048422711159     kcypryk@mp.pl    
Principal Investigator: Katarzyna Cypryk, PhD, MD ,            
Sub-Investigator: Marcin Kosiński, MD            
Sponsors and Collaborators
Medical Universtity of Lodz
Investigators
Principal Investigator: Katarzyna Cypryk, MD , PhD, Habilitation Medical University in Lodz
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00265746     History of Changes
Other Study ID Numbers: KBN Nr 2 P05001 28
Study First Received: December 14, 2005
Last Updated: February 27, 2006
Health Authority: Poland: Ministry of Science and Higher Education

Keywords provided by Medical Universtity of Lodz:
metformin
gestational diabetes
lifestyle

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Pregnancy Complications
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013