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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014