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Prevention of Gestational Diabetes

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ClinicalTrials.gov Identifier: NCT01130012
Recruitment Status : Completed
First Posted : May 25, 2010
Last Update Posted : December 15, 2010
Sponsor:
Collaborator:
South Ostrobothnia Hospital District
Information provided by:
Kuopio University Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Gestational Diabetes Behavioral: Lifestyle: diet and exercise Behavioral: Close follow-up: reporting diaries of food and exercise Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Feasibility of a Lifestyle Intervention in Early Risk Pregnancy in Preventing Deterioration in Glucose Tolerance?
Study Start Date : April 2005
Actual Primary Completion Date : May 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Number of at risk participants developing GDM during pregnancy

Secondary Outcome Measures :
  1. The effect of intervention on fetal growth


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130012


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

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
First Posted: May 25, 2010    Key Record Dates
Last Update Posted: December 15, 2010
Last Verified: December 2010

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

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