NCT00265746

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Last Updated

March 18, 2019

Status Verified

March 1, 2019

Enrollment Period

1.2 years

First QC Date

December 14, 2005

Last Update Submit

March 14, 2019

Conditions

Type 2 Diabetes Mellitus

Keywords

metformingestational diabeteslifestyle

Outcome Measures

Primary Outcomes (1)

  • Incidence of type 2 diabetes mellitus.

Secondary Outcomes (1)

  • Incidence of IGT

Interventions

MetforminDRUG
Lifestyle intervention - diet, physical activityBEHAVIORAL

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes, Gestational

Interventions

MetforminExercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Katarzyna Cypryk, MD, PhD, Habilitation

    Medical University in Lodz

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 14, 2005

First Posted

December 15, 2005

Study Start

November 1, 2005

Primary Completion

January 1, 2007

Last Updated

March 18, 2019

Record last verified: 2019-03