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

Gestational Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01158131
• Other study ID #: 2009p002118
• Status: Completed
• Phase: Phase 2
• First received: June 28, 2010
• Last updated: December 21, 2012
• Start date: November 2009
• Est. completion date: September 2012

Study information

• Verified date: December 2012
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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-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.

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, Barrett-Connor et al. 2002). These findings were consistent, regardless of ethnicity, age, body mass index (BMI), gender (Knowler, Barrett-Connor et al. 2002). However, the DPP lacks a specific focus on new mothers with a recent history of gestational diabetes despite their documented high risk for developing Type 2 diabetes. Although there are recommendations that all women with gestational diabetes mellitus (GDM) receive postpartum testing for diabetes and type 2 diabetes risk reduction, study findings suggest that women with a recent history of GDM may be unaware of their risk for future diabetes, and also do not take steps to reduce their risks (Kim et al., 2007). The postpartum period is also a time when many changes occur in a woman's life, with competing responsibilities often altering sleep patterns, work schedules, eating patterns, exercise regularity, and time allocation (Walker, 1999; Swan et al., 2007). New mothers may have difficulties engaging in healthy lifestyle programs because of lack of time and energy, and because of competing work and family demands, including child care (Swan, Kilmartin, and Liaw, 2007).

Modeled around the barriers identified in literature and gleaned from the focus groups and informant interviews of the preliminary study (2009p-000042), we have created a lifestyle/behavioral intervention that utilizes a modified DPP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

Behavioral:
• Balance after Baby Lifestyle Intervention Program
Participants in this intervention will receive support from a lifestyle coach and gain access to a website with online presentations that contain healthy eating and physical activity educational tips. Weekly phone conversations with the lifestyle coach, as well as logging diet and physical activity will also be required of intervention participants.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postpartum weight loss	Postpartum weight loss for all subjects will be assessed.	12 months after delivery	No