Overview

This trial is active, not recruiting.

Condition gestational diabetes mellitus
Sponsor Vanderbilt University
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date June 2014
End date December 2016
Trial size 89 participants
Trial identifier NCT02388958, 140295, P30DK092986

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm

Primary Outcomes

Measure
Postpartum weight change measured in kilograms
time frame: 6 months (change in weight from the time of delivery to 6 months postpartum)

Secondary Outcomes

Measure
Rate of pregnancy weight gain prior to GDM diagnosis measured in kilograms per week
time frame: 24-28 weeks
Rate of pregnancy weight gain after GDM diagnosis measured in kilograms per week
time frame: 10-16 weeks
Change in perceived risk of developing diabetes during versus after pregnancy measured with the Risk Perception Survey for Developing Diabetes (RPS-DD)
time frame: 10 months
Change in dietary choices during versus after pregnancy measured with the Personal Diabetes Questionnaire
time frame: 10 months

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria for women with GDM: - 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. Inclusion Criteria for women without GDM: - 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 for both cohorts: - Diagnosis of type 1 or type 2 diabetes prior to pregnancy. - Diagnosis of GDM prior to 20 weeks gestation. - Patient does not speak English.

Additional Information

Official title Weight Changes During and After Pregnancy in Women With Gestational Diabetes
Principal investigator Rosette Chakkalakal, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Vanderbilt University.