Weight Changes During and After Pregnancy in Women With Gestational Diabetes

Gestational Diabetes Mellitus Clinical Trial

Official title:

Weight Changes During and After Pregnancy in Women With Gestational Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02388958
• Other study ID #: 140295
• Secondary ID: P30DK092986
• Status: Completed
• Phase: N/A
• First received: March 9, 2015
• Last updated: January 18, 2017
• Start date: June 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight Changes
• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postpartum weight change measured in kilograms		6 months (change in weight from the time of delivery to 6 months postpartum)
Secondary	Rate of pregnancy weight gain prior to GDM diagnosis measured in kilograms per week		24-28 weeks
Secondary	Rate of pregnancy weight gain after GDM diagnosis measured in kilograms per week		10-16 weeks
Secondary	Change in perceived risk of developing diabetes during versus after pregnancy measured with the Risk Perception Survey for Developing Diabetes (RPS-DD)		10 months
Secondary	Change in dietary choices during versus after pregnancy measured with the Personal Diabetes Questionnaire		10 months