Weight Changes During and After Pregnancy in Women With Gestational Diabetes

NCT02388958 | Completed

• 2 other identifiers: 140295P30DK092986
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Postpartum weight change measured in kilograms

  6 months (change in weight from the time of delivery to 6 months postpartum)

Secondary Outcomes (4)

• 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

Study Arms (2)

Women with GDM

Women without GDM

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-8300, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Rosette Chakkalakal, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 17, 2015
• Study Start: June 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 20, 2017

Record last verified: 2017-01

Locations

US (1)