Prevention of Gestational Diabetes

This study has been completed.
Sponsor:
Collaborator:
South Ostrobothnia Hospital District
Information provided by:
Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT01130012
First received: May 11, 2010
Last updated: December 14, 2010
Last verified: December 2010
  Purpose

Gestational diabetes mellitus (GDM)is a major health problem

  • growing prevalence of obesity
  • the older age of pregnant women

A randomized controlled trial in 54 pregnant voluntary women at high risk for GDM.

  • feasibility of an early intervention
  • glucose tolerance at weeks 26-28

Condition Intervention
Gestational Diabetes
Behavioral: Lifestyle: diet and exercise
Behavioral: Close follow-up: reporting diaries of food and exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Feasibility of a Lifestyle Intervention in Early Risk Pregnancy in Preventing Deterioration in Glucose Tolerance?

Resource links provided by NLM:


Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • Number of at risk participants developing GDM during pregnancy [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The effect of intervention on fetal growth [ Designated as safety issue: Yes ]

Enrollment: 440
Study Start Date: April 2005
Study Completion Date: December 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lifestyle, follow-up, early care, standard care high/low risk
Lifestyle: The women received counseling by a clinical nutritionist six times and by a physiotherapist six times during pregnancy.
Behavioral: Lifestyle: diet and exercise
Lifestyle: The women received counseling by a clinical nutritionist six times and by a physiotherapist six times during pregnancy.
Close follow-up
Follow-up: The women received information of the results of a glucose tolerance test (OGTT), reported food records three times during pregnancy, exercise history and exercise diaries monthly.
Behavioral: Close follow-up: reporting diaries of food and exercise
Follow-up: The women received information of the results of a glucose tolerance test (OGTT), reported food records three times during pregnancy, exercise history and exercise diaries monthly.

Detailed Description:
  1. A 75-g oral glucose tolerance test (OGTT) was performed at weeks 8-12

    1. voluntary women in early pregnancy (n=96)
    2. 54 high risk mothers were randomized

      • lifestyle intervention group (n=27)
      • close follow-up (n=27)
  2. An OGTT was performed again at weeks 26-28

    • the lifestyle intervention group (n=27)
    • the close follow-up group (n=27)
    • other high-risk women of the early care group (n=42)who were not randomized
  3. An OGTT was also performed at weeks 26-28 in two neighboring municipalities

    • a standard care high-risk group(n=171)who did not undergo early intervention
  4. Primary outcomes

    • number of at risk participants developing GDM during pregnancy in the two arms
  5. Secondary outcomes

    • the effect of intervention on fetal growth
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • high risk for gestational diabetes
  • fasting glucose 4.8-5.5 mmol/l and 2-hour glucose of OGTT <7.8 mmol/l

Exclusion Criteria:

  • normal glucose tolerance at weeks 8-12
  • gestational diabetes at weeks 8-12
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130012

Sponsors and Collaborators
Kuopio University Hospital
South Ostrobothnia Hospital District
Investigators
Principal Investigator: Eeva Korpi-Hyövälti, MD South Ostrobothnia Hospital District
  More Information

No publications provided by Kuopio University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Leo Niskanen PhD Prof, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT01130012     History of Changes
Other Study ID Numbers: KUH16032005
Study First Received: May 11, 2010
Last Updated: December 14, 2010
Health Authority: Finland: Research Ethics Committee, South Ostrobothnia Hospital District

Keywords provided by Kuopio University Hospital:
Gestational diabetes mellitus
Lifestyle intervention
Oral glucose tolerance test
Insulin treatment
Pregnancy outcomes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on April 17, 2014