Gestational DiabetesNCT02082301
Oral Glucose Tolerance Testing After Gestational Diabetes
An observational study of Gestational Diabetes and Pregnancy, run by MetroHealth Medical Center at 2 sites in United States.
Trial summary
This is an observation study of women with gestational diabetes. Subjects recruited undergo immediate postpartum diabetic screening prior to discharge. Post-partum screening for overt diabetes is repeated 6-12 weeks postpartum. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes, Pregnancy, Obesity
- How many people
- 118 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2012to 31 Dec 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Primary cohort is obtained from a pregnant population at two academic medical centers.
Who may be able to join
- Singleton pregnancy
- Gestational diabetes
Who cannot join
- Multiple gestations
- pre-pregnancy diabetes
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Hospital
Cleveland, Ohio, 44106
MetroHealth Medical Center
Cleveland, Ohio, 44109
About this study
This is an observation study of women with gestational diabetes. Subjects recruited undergo immediate postpartum diabetic screening prior to discharge. Post-partum screening for overt diabetes is repeated 6-12 weeks postpartum. The outcome of interest is the utility of an immediate post partum screen for overt diabetes compared to a traditional 6 week test.
- Conditions
- Gestational Diabetes, Pregnancy, Obesity
- Medical subject headings
- Diabetes, Gestational, Obesity
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 |
|---|---|---|
| Gestational diabetes | Primary cohort is women with diagnosis of gestational diabetes without evidence of overt diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome: sensitivity of immediate post partum screen
2 hour fasting 75g OGTT immediately post partum. This is compared to a traditional 6 week post partum 75g OGTT for the sensitivity, positive and negative predictive value of the immediate post partum test
Measured: Immediate post partum
Secondary outcomes (1)
Secondary outcome: physiology
A small sub-cohort of women will undergo an additional 2 hour fasting 75g OGTT in the third trimester with measurements of insulin, cytokines, lipids.
Measured: 3 time points: antepatum, immediate postpartum, 6 weeks post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study startOct 2012
- Primary completion4 May 2016
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Loyola University
- Responsible party
- Principal investigator, Ted Waters, MetroHealth Medical Center
- Investigators
- Thaddeus Waters, MD, Principal investigator, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082301
- Sponsor's protocol ID
- IRB12-00581
- Status last verified
- Feb 2020
- First submitted
- 6 Mar 2014
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Waters TP, Kim SY, Sharma AJ, Schnellinger P, Bobo JK, Woodruff RT, Cubbins LA, Haghiac M, Minium J, Presley L, Wolfe H, Hauguel-de Mouzon S, Adams W, Catalano PM. Longitudinal changes in glucose metabolism in women with gestational diabetes, from late pregnancy to the postpartum period. Diabetologia. 2020 Feb;63(2):385-394. doi: 10.1007/s00125-019-05051-0. Epub 2019 Dec 9.
PubMed 31820038
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Glucose Tolerance Testing After Gestational Diabetes
- ClinicalTrials.gov ID
- NCT02082301
- Acronym / sponsor ID
- IRB12-00581
- Conditions
- Gestational Diabetes, Pregnancy, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Loyola University
- Study start
- Oct 2012
- Primary completion
- 4 May 2016 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 10 Mar 2014 (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.
This is an observation study of women with gestational diabetes. Subjects recruited undergo immediate postpartum diabetic screening prior to discharge. Post-partum screening for overt diabetes is repeated 6-12 weeks postpartum. The outcome of interest is the utility of an immediate post partum screen for overt diabetes compared to a traditional 6 week test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gestational diabetes | – | –Primary cohort is women with diagnosis of gestational diabetes without evidence of overt diabetes |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary cohort is obtained from a pregnant population at two academic medical centers.
Key inclusion criteria (2 listed)
- Singleton pregnancy
- Gestational diabetes
Key exclusion criteria (2 listed)
- Multiple gestations
- pre-pregnancy diabetes
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
Primary outcome: sensitivity of immediate post partum screen
Time frame: Immediate post partum
2 hour fasting 75g OGTT immediately post partum. This is compared to a traditional 6 week post partum 75g OGTT for the sensitivity, positive and negative predictive value of the immediate post partum test
1 secondary outcome
Secondary outcome: physiology
Time frame: 3 time points: antepatum, immediate postpartum, 6 weeks post partum
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 25 Feb 2020.
- Derived from this study: PubMed 31820038Waters TP, Kim SY, Sharma AJ, Schnellinger P, Bobo JK, Woodruff RT, Cubbins LA, Haghiac M, Minium J, Presley L, Wolfe H, Hauguel-de Mouzon S, Adams W, Catalano PM. Longitudinal changes in glucose metabolism in women with gestational diabetes, from late pregnancy to the postpartum period. Diabetologia. 2020 Feb;63(2):385-394. doi: 10.1007/s00125-019-05051-0. Epub 2019 Dec 9.
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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.
Thaddeus Waters, MD principal investigator
Loyola University
2 sites 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 and Pregnancy, run by MetroHealth Medical Center at 2 sites 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 2 inclusion and 2 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 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Primary outcome: sensitivity of immediate post partum screen (time frame: Immediate post partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02082301, which also lists 1 linked publication.
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 25 Feb 2020.