Prevention of Gestational Diabetes

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01130012
• Other study ID #: KUH16032005
• Status: Completed
• Phase: N/A
• First received: May 11, 2010
• Last updated: December 14, 2010
• Start date: April 2005
• Est. completion date: December 2006

Study information

• Verified date: December 2010
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Research Ethics Committee, South Ostrobothnia Hospital District
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: December 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

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: 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kuopio University Hospital	South Ostrobothnia Hospital District

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of at risk participants developing GDM during pregnancy			Yes
Secondary	The effect of intervention on fetal growth			Yes