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Clinical Trials/NCT01130012
NCT01130012CompletedNot Applicable

Feasibility of a Lifestyle Intervention in Early Risk Pregnancy in Preventing Deterioration in Glucose Tolerance?

Kuopio University Hospital0 sites440 target enrollmentStarted: April 1, 2005Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
440
Primary Endpoint
Number of at risk participants developing GDM during pregnancy
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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

Detailed Description

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

  2. voluntary women in early pregnancy (n=96)

  3. 54 high risk mothers were randomized

  • lifestyle intervention group (n=27)
  • close follow-up (n=27)
  1. 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
  1. 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
  1. Primary outcomes

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Number of at risk participants developing GDM during pregnancy

Secondary Outcomes

  • The effect of intervention on fetal growth

Investigators

Sponsor
Kuopio University Hospital
Sponsor Class
Other

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