Weight Changes During and After Pregnancy in Women With Gestational Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes Mellitus

• Study Type: Observational
• Enrollment (Actual): 89

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232-8300
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All women receiving prenatal care at Vanderbilt University Medical Center who do not already carry a diagnosis of type 1 or type 2 diabetes are screened for GDM between weeks 24-28 of pregnancy with a non-fasting 50-gram glucose tolerance test (GTT). Blood glucose values greater than or equal to 140 on this screening test are considered positive. Women with a positive screening test undergo a diagnostic fasting 100-gram 3-hour GTT. GDM is diagnosed if a woman has 2 or more abnormal values on the 3-hour GTT (abnormal values are fasting blood glucose greater than or equal to 95, 1-hour blood glucose greater than or equal to 180, 2-hour blood glucose greater than or equal to 155 and/or 3-hour blood glucose greater than or equal to 140). By reviewing the electronic medical record of women with singleton pregnancies undergoing GTT on a weekly basis, we will identify women with and without GDM.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Women with GDM
Women without GDM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postpartum weight change measured in kilograms	6 months (change in weight from the time of delivery to 6 months postpartum)

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of pregnancy weight gain prior to GDM diagnosis measured in kilograms per week	24-28 weeks
Rate of pregnancy weight gain after GDM diagnosis measured in kilograms per week	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)	10 months
Change in dietary choices during versus after pregnancy measured with the Personal Diabetes Questionnaire	10 months

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Rosette Chakkalakal, MD, Vanderbilt University

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: March 9, 2015
• First Submitted That Met QC Criteria: March 9, 2015
• First Posted (Estimate): March 17, 2015

Study Record Updates

• Last Update Posted (Estimate): January 20, 2017
• Last Update Submitted That Met QC Criteria: January 18, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight; Pregnancy Complications; Diabetes Mellitus; Body Weight Changes; Diabetes, Gestational
• Other Study ID Numbers: 140295; P30DK092986 (U.S. NIH Grant/Contract)