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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Metformin
Lifestyle intervention - diet, physical activity
Sponsored by
Medical University of Lodz
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes Mellitus focused on measuring metformin, gestational diabetes, lifestyle

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Incidence of type 2 diabetes mellitus.

    Secondary Outcome Measures

    Incidence of IGT

    Full Information

    First Posted
    December 14, 2005
    Last Updated
    March 14, 2019
    Sponsor
    Medical University of Lodz
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00265746
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    November 2005 (Anticipated)
    Primary Completion Date
    January 1, 2007 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Medical University of Lodz

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes Mellitus
    Keywords
    metformin, gestational diabetes, lifestyle

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Metformin
    Intervention Type
    Behavioral
    Intervention Name(s)
    Lifestyle intervention - diet, physical activity
    Primary Outcome Measure Information:
    Title
    Incidence of type 2 diabetes mellitus.
    Secondary Outcome Measure Information:
    Title
    Incidence of IGT

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Katarzyna Cypryk, MD, PhD, Habilitation
    Organizational Affiliation
    Medical University in Lodz
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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