Status:
COMPLETED
Efficacy of Behavioral Therapy and Exercise in Gestational Diabetes Mellitus (GDM)
Lead Sponsor:
University of Turin, Italy
Conditions:
Birth-weight
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to test whether four lifestyle intervention programs (diet alone; diet and behavioral therapy, diet and exercise, diet and behavioral therapy and exercise), delivered to wo...
Detailed Description
Women with gestational diabetes (GDM) are at increased risk of adverse pregnancy and neonatal outcomes. It is estimated that most women diagnosed with GDM can achieve targeted glycemic goals with nutr...
Eligibility Criteria
Inclusion
- Gestational age between 24 and 26 weeks
- Diagnosis of GDM at the 75g oral glucose tolerance test (OGTT)
- Singleton pregnancy
Exclusion
- Body mass index \> 40 or \< 12kg/m2
- Any known diseases (pre-existing diabetes mellitus, cardiovascular diseases, liver/kidney diseases, cancers, arterial hypertension)
- Patients on any drugs
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01506310
Start Date
July 1 2009
End Date
June 1 2012
Last Update
January 23 2013
Active Locations (1)
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1
University of Turin
Turin, Italy, Italy, 10126