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

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

Overview[ - collapse ][ - ]

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	Type 2 Diabetes Mellitus
Intervention	Drug: Metformin Behavioral: Lifestyle intervention - diet, physical activity
Phase	Phase 4
Sponsor	Medical Universtity of Lodz
Responsible Party	Medical Universtity of Lodz
ClinicalTrials.gov Identifier	NCT00265746
First Received	December 14, 2005
Last Updated	February 27, 2006
Last verified	December 2005

Tracking Information[ + expand ][ + ]

First Received Date	December 14, 2005
Last Updated Date	February 27, 2006
Start Date	November 2005
Estimated Primary Completion Date	Not Provided
Current Primary Outcome Measures	Incidence of type 2 diabetes mellitus.
Current Secondary Outcome Measures	Incidence of IGT

Descriptive Information[ + expand ][ + ]

Brief Title	Prevention of Diabetes Mellitus Development in Women Who Had Already Experienced A Gestational Diabetes
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.
Brief 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.
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.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: Metformin Behavioral: Lifestyle intervention - diet, physical activity
Study Arm (s)	Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	300
Estimated Completion Date	Not Provided
Estimated Primary Completion Date	Not Provided
Eligibility 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
Gender	Female
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Katarzyna Cypryk, MD, PhD, Habilitation 0048422711159 kcypryk@mp.pl
Location Countries	Poland

Administrative Information[ + expand ][ + ]

NCT Number	NCT00265746
Other Study ID Numbers	KBN Nr 2 P05001 28
Has Data Monitoring Committee	Not Provided
Information Provided By	Medical Universtity of Lodz
Study Sponsor	Medical Universtity of Lodz
Collaborators	Not Provided
Investigators	Principal Investigator: Katarzyna Cypryk, MD , PhD, Habilitation Medical University in Lodz
Verification Date	December 2005

Locations[ + expand ][ + ]

Department of Endocrinology and Isotope Therapy, Polish Mother’s Memorial Hospital, Research Institute, Lodz	Lodz, Poland Contact: Katarzyna Cypryk, M D, PhD , Habilitation \| 0048422711159 \| kcypryk@mp.pl Principal Investigator: Katarzyna Cypryk, PhD, MD , Recruiting