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Completed

NCT Number: NCT01130012

Prevention of Gestational Diabetes

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

Completed

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

  • A 75-g oral glucose tolerance test (OGTT) was performed at weeks 8-12
  • voluntary women in early pregnancy (n=96)
  • 54 high risk mothers were randomized
  • lifestyle intervention group (n=27)
  • close follow-up (n=27)
  • 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
  • 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
  • Primary outcomes
  • number of at risk participants developing GDM during pregnancy in the two arms
  • Secondary outcomes
  • the effect of intervention on fetal growth

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle: diet and exercise

Behavioral

Lifestyle: The women received counseling by a clinical nutritionist six times and by a physiotherapist six times during pregnancy.

Close follow-up: reporting diaries of food and exercise

Behavioral

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 outcomes

  1. Number of at risk participants developing GDM during pregnancy

Secondary outcomes

  1. The effect of intervention on fetal growth

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Collaborators

  • South Ostrobothnia Hospital District

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
May 25, 2010
Registry last updated
Dec 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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