Gestational Diabetes MellitusNCT02388958
Weight Changes During and After Pregnancy in Women With Gestational Diabetes
An observational study of Gestational Diabetes Mellitus, run by Vanderbilt University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Diagnosis of type 1 or type 2 diabetes prior to pregnancy.
- Diagnosis of GDM prior to 20 weeks gestation.
- Patient does not speak English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-8300
About this study
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
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with GDM | Not described | |
| Women without GDM | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum weight change measured in kilograms
Measured: 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
Measured: 24-28 weeks
Rate of pregnancy weight gain after GDM diagnosis measured in kilograms per week
Measured: 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)
Measured: 10 months
Change in dietary choices during versus after pregnancy measured with the Personal Diabetes Questionnaire
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startJun 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosette Chakkalakal, Vanderbilt University
- Investigators
- Rosette Chakkalakal, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388958
- Sponsor's protocol ID
- 140295
- Other IDs
- P30DK092986
- Status last verified
- Jan 2017
- First submitted
- 9 Mar 2015
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Changes During and After Pregnancy in Women With Gestational Diabetes
- ClinicalTrials.gov ID
- NCT02388958
- Acronym / sponsor ID
- 140295
- Conditions
- Gestational Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jun 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with GDM | – | – |
| Women without GDM | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Diagnosis of type 1 or type 2 diabetes prior to pregnancy.
- Diagnosis of GDM prior to 20 weeks gestation.
- Patient does not speak English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postpartum weight change measured in kilograms
Time frame: 6 months (change in weight from the time of delivery to 6 months postpartum)
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosette Chakkalakal, MD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes Mellitus, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum weight change measured in kilograms (time frame: 6 months (change in weight from the time of delivery to 6 months postpartum)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2017.