Status:
COMPLETED
Comprehensive Postpartum Screening Strategies for Women With Gestational Diabetes Mellitus (GDM)
Lead Sponsor:
Woman's
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
FEMALE
18-40 years
Brief Summary
Previous gestational diabetes (GDM) predisposes affected women to diabetes. Pregnancy, in essence, serves as a metabolic stress test and uncovers underlying insulin resistance and ß-cell dysfunction. ...
Detailed Description
Women with previous gestational diabetes constitute an ideal group for the development, testing, and implementation of clinical strategies for primary diabetes prevention. One-third to one-half of wom...
Eligibility Criteria
Inclusion
- Postpartum Women (6-12 weeks)who experienced GDM during index pregnancy 18 years to 42 years of age
- English-speaking
- Written consent for participation in the study
- Exclusion Criteria (Medical):
- Cholestasis during the past pregnancy
- Serum AST and/or ALT level exceeding more than twice normal laboratory values
- History or clinical manifestation of cardiovascular disease
- History or clinical manifestation of diabetes or use of anti-diabetic drugs before pregnancy
- History or clinical manifestation of any other significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, immune, hepatic, renal, urologic disorders, or cancer
- Regular use of medications for weight control, psychosis and hormonal birth control
- Current use of medication to treat diabetes
- Exclusion Criteria (Psychiatric and Behavioral):
- History or clinical manifestation of any eating disorder
- Individuals who smoke
- History of drug or alcohol abuse (up to 14 drinks a week are allowed) within the past two years
- Other
Exclusion
- Pregnancy or pregnancy planned during the coming year
- Not willing or unable to adhere to the clinical evaluation schedule over the twelve -month study period
Key Trial Info
Start Date :
July 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT00849849
Start Date
July 1 2011
End Date
December 1 2013
Last Update
December 18 2014
Active Locations (1)
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1
Woman's Hospital Research Institute
Baton Rouge, Louisiana, United States, 70815