Weight Changes During and After Pregnancy in Women With Gestational Diabetes

NCT ID: NCT02388958

Last Updated: 2017-01-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 89 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-12-31

Brief Summary

Gestational diabetes mellitus (GDM) is associated with short-term and long-term complications for infants and mothers. The management of GDM during pregnancy focuses on reducing risks to the infant associated with hyperglycemia. The postpartum management of GDM focuses on reducing maternal risk of developing type 2 diabetes (T2DM). A diagnosis of GDM identifies up to 31% of parous women who will eventually develop T2DM and approximately 50% of women diagnosed with GDM will develop T2DM in the first 5 years postpartum. The perceived risk of developing short-term and/or long-term complications of GDM may influence women's likelihood of engaging in diet modification, the mainstay of treatment of GDM, both during and after pregnancy. If sustained after delivery, diet modifications introduced as treatment for GDM could affect maternal weight changes during and after pregnancy, which could in turn affect T2DM risk. It is unknown if and how women with GDM differ in their perceived risk of developing T2DM, dietary choices, or weight gain (and retention) during versus after pregnancy. Therefore, the project proposed in this application seeks to (1) characterize the perceived risk of developing T2DM among women with GDM during and after pregnancy, (2) characterize dietary choices of women with GDM during and after pregnancy, and (3) characterize weight changes of women with GDM during and after pregnancy as compared to women without GDM.

Conditions

Gestational Diabetes Mellitus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Women with GDM

No interventions assigned to this group

Women without GDM

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patient is currently pregnant with a singleton pregnancy.
• Laboratory confirmed diagnosis of GDM between weeks 24-28 gestation.
• Patient is receiving routine prenatal care at Vanderbilt University Medical Center.

• Patient is currently pregnant with a singleton pregnancy.
• Patient does not have GDM based on non-fasting and/or fasting GTT results.
• Patient is receiving routine prenatal care at Vanderbilt University Medical Center.

Exclusion Criteria

• Diagnosis of type 1 or type 2 diabetes prior to pregnancy.
• Diagnosis of GDM prior to 20 weeks gestation.
• Patient does not speak English.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Rosette Chakkalakal

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rosette Chakkalakal, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

P30DK092986

Identifier Type: NIH

Identifier Source: secondary_id

View Link

140295

Identifier Type: -

Identifier Source: org_study_id