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OpenTrials
Completed

NCT Number: NCT02388958

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-8300, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Postpartum weight change measured in kilograms

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

Secondary outcomes

  1. Rate of pregnancy weight gain prior to GDM diagnosis measured in kilograms per week

    Time frame: 24-28 weeks

  2. Rate of pregnancy weight gain after GDM diagnosis measured in kilograms per week

    Time frame: 10-16 weeks

  3. 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

  4. Change in dietary choices during versus after pregnancy measured with the Personal Diabetes Questionnaire

    Time frame: 10 months

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

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

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 17, 2015
Registry last updated
Jan 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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