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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01158131
• Date of registration: 28/06/2010
• Prospective Registration: No
• Primary sponsor: Brigham and Women's Hospital
• Public title: Diabetes Prevention in Women With a Recent History of Gestational Diabetes Mellitus (GDM)
• Scientific title: Diabetes Prevention in Women With a Recent History of Gestational Diabetes Mellitus (GDM)
• Date of first enrolment: November 2009
• Target sample size: 75
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01158131
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Ellen W Seely, MD
• Affiliation: Brigham and Women's Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Gestational Diabetes Mellitus

Intervention(s)

Behavioral: Balance after Baby Lifestyle Intervention Program

Primary Outcome(s)

Postpartum weight loss [Time Frame: 12 months after delivery]

Secondary ID(s)

2009p002118

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Centers for Disease Control and Prevention