Diabetes Prevention in Women With a Recent History of Gestational Diabetes Mellitus (GDM)

Completed · Phase 2

Conditions studied: Gestational Diabetes Mellitus

In brief

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-based lifestyle intervention program adapted from the NIH sponsored Diabetes Prevention Program (DPP), modified specifically for women with a recent history of GDM, incorporating advice about diet and physical activity, delivered in the first 12 months after delivery will help women lose weight, improve overall health, and decrease their risk factors for type 2 diabetes.

Key facts

Study ID

NCT01158131

Run by

Brigham and Women's Hospital

People needed

75

Starts

2009-11-01

Expected to finish

2012-09-01

Last updated by the study team

2012-12-24

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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