Status:
COMPLETED
Diabetes Prevention in Women With a Recent History of Gestational Diabetes Mellitus (GDM)
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Centers for Disease Control and Prevention
Conditions:
Gestational Diabetes Mellitus
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
Many studies have shown that women with a history of gestational diabetes mellitus (GDM) have an increased risk of developing diabetes later in life. The purpose of the study is to test whether a web-...
Detailed Description
The landmark Diabetes Prevention Program (DPP) demonstrated that intensive lifestyle intervention in people with impaired glucose tolerance (IGT) could reduce the incidence of type 2 diabetes (Knowler...
Eligibility Criteria
Inclusion
- Healthy female with a diagnosis of gestational diabetes mellitus (GDM) by Carpenter-Coustan criteria (see below) in most recent singleton or twin pregnancy (Carpenter \& Coustan, 1982)
- Women with a glucose value \>200 mg/dL after a 50-g glucose challenge test at \>12 weeks' gestation will also be included
- 18-45 years old
- No personal history of Type 1 or 2 diabetes
- Pre-pregnancy body mass index between 18 and 40 kg/m2
- Six weeks postpartum body mass index between 25 and 50 kg/m2
- Capable of providing informed consent
Exclusion
- Pre-pregnancy diagnosis of diabetes (type 1, 2, or a secondary form of diabetes)
- Pre-pregnancy body mass index \<18 kg/m2 (underweight) or \>40 kg/m2 (morbidly obese)
- Current pregnancy
- Six weeks postpartum body mass index \<25 kg/m2 or \>50 kg/m2
- Excessive alcohol intake defined as \>1 beverage per night or past history of alcohol abuse (within the previous 5 years)
- Current or past recreational drug use (within the previous 5 years)
- Diagnosis of diseases associated with glucose metabolism
- Taking certain prescription medication including glucocorticoids, atypical antipsychotics associated with weight gain (such as respirdal(respiradone), clozapine (klozaril), olanzapine (zyprexa), quetiapine (seroquel), etc.) or weight loss medications including prescription, non-prescription or herbal medications
- Personal history of breast cancer or any other type of cancer other than a basal cell skin cancer
- Personal history of cardiovascular disease (coronary artery disease, congestive heart failure, valvular heart disease, stroke, transient ischemic attack, or intermittent claudication), kidney disease, liver disease, venous or arterial thromboembolic disease, adrenal insufficiency, depression requiring hospitalization within the past 6 months, or non-pregnancy related illness requiring overnight hospitalization in the past 6 months
- Underlying disease/treatment that might interfere with participation in/completion of the study (e.g., significant gastrointestinal conditions, major psychiatric disorders, and others at the discretion of the study clinician)
- Other active medical problems detected by examination or laboratory testing
- Plans to be in a different geographic area within the year
- Unable to give informed consent
- Non-English speaking
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01158131
Start Date
November 1 2009
End Date
September 1 2012
Last Update
December 24 2012
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115