Gestational DiabetesGGTUAGDMNCT04956094
GGT and Uric Acid to Predict Gestational Diabetes Mellitus
An observational study of Gestational Diabetes, run by Mount Carmel Health System at 1 site in United States.
Trial summary
Gestational Diabetes Mellitus (GDM) is a common metabolic complication of pregnancy defined as new onset hyperglycemia during gestation. GDM conveys significant risk of morbidity and mortality for both mother and infant. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- GGT/Uric Acid
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2021to 31 Dec 2024
- 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: Pregnant women between > 9 weeks and < 14 and 0 weeks gestation presenting to the OB clinic for prenatal care
Who may be able to join
- Pregnant women between > 9 weeks and < 14.0 weeks gestation
Who cannot join
- Known history of or current diagnosis of type I or type II diabetes mellitus
- Known liver disease
- Known kidney disease
- Known history of or current diagnosis of gout
- Known history of alcoholism or current alcohol use
- Multiple gestation
- < 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Elevated Serum Gamma Glutamyl Transferase (GGT) and Uric Acid at 9-14 Weeks Gestation With the Development of Gestational Diabetes Mellitus (GDM)
Gestational Diabetes Mellitus (GDM) is a common metabolic complication of pregnancy defined as new onset hyperglycemia during gestation. GDM conveys significant risk of morbidity and mortality for both mother and infant. An estimated 268,900 infants were born to mothers with GDM in the USA, accounting for approximately 6.9% of births. Although individual correlations have been found between elevated GGT and uric acid levels and later development of GDM, no research has established and validated combined criteria for GGT and uric acid levels that would lead to their use in identifying women at high risk of GDM in the first trimester.
Central Hypothesis: Serum GGT and serum uric acid collected between >9-14.0 weeks gestation will be significantly elevated in women who later develop GDM compared to those who do not. Combined analysis of serum uric acid and GGT levels within the first trimester allows for accurate prediction of the development of GDM.
Study population includes women between 9-14 weeks gestation undergoing a standard first trimester blood draw. Additional blood will be drawn during the standard blood draw to assess GGT and uric acid levels. Research participants will be tracked afterwards to determine whether they tested positive for gestational diabetes during the standard testing process which typically occurs at 24-28 weeks gestation. The data will then be analyzed to estimate the sensitivity, specificity, positive and negative predictive values of the first trimester GGT and uric acid tests. The GGT and uric acid levels which maximize the area under the receiver-operator characteristic curve will be identified.
- Conditions
- Gestational Diabetes
- Being tested
- GGT/Uric Acid
- Keywords
- Pregnancy, Screening, Gamma Glutamyl Transferase, Serum Uric Acid, Sensitivity, Specificity, Predictive Value
- Medical subject headings
- Diabetes, Gestational, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GGT/Uric AcidDiagnostic test
Standard laboratory blood testing for GGT and uric acid levels.
| Study group | Role | What they receive |
|---|---|---|
| First Trimester Prenatal Visit | Women attending an initial first trimester prenatal visit who will be undergoing a standard blood draw. Receives: Diagnostic Test: GGT/Uric Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients diagnosed with gestational diabetes mellitus
Diagnosis of gestational diabetes mellitus (GDM) via oral glucose tolerance testing (Carpenter and Coustan criteria)
Measured: 24-28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start21 Jun 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: Principal Investigator left the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Carmel Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Carmel Foundation
- Responsible party
- Sponsor
- Investigators
- James Dombroski, MD, Study chair, Mount Carmel Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956094
- Sponsor's protocol ID
- 210412-1
- Acronym
- GGTUAGDM
- Status last verified
- Nov 2024
- First submitted
- 30 Jun 2021
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data with others. Study data may be requested from the sponsor or investigator.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Elevated Serum Gamma Glutamyl Transferase (GGT) and Uric Acid at 9-14 Weeks Gestation With the Development of Gestational Diabetes Mellitus (GDM)
- ClinicalTrials.gov ID
- NCT04956094
- Acronym / sponsor ID
- GGTUAGDM / 210412-1
- Conditions
- Gestational Diabetes
- Keywords
- Pregnancy, Screening, Gamma Glutamyl Transferase, Serum Uric Acid, Sensitivity, Specificity, Predictive Value
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Principal Investigator left the institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mount Carmel Health SystemUniversity, hospital or other
- Collaborators
- Mount Carmel Foundation
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Jul 2021 (actual)
- 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 a common metabolic complication of pregnancy defined as new onset hyperglycemia during gestation. GDM conveys significant risk of morbidity and mortality for both mother and infant. An estimated 268,900 infants were born to mothers with GDM in the USA, accounting for approximately 6.9% of births. Although individual correlations have been found between elevated GGT and uric acid levels and later development of GDM, no research has established and validated combined criteria for GGT and uric acid levels that would lead to their use in identifying women at high risk of GDM in the first trimester.
Central Hypothesis: Serum GGT and serum uric acid collected between >9-14.0 weeks gestation will be significantly elevated in women who later develop GDM compared to those who do not. Combined analysis of serum uric acid and GGT levels within the first trimester allows for accurate prediction of the development of GDM.
Study population includes women between 9-14 weeks gestation undergoing a standard first trimester blood draw. Additional blood will be drawn during the standard blood draw to assess GGT and uric acid levels. Research participants will be tracked afterwards to determine whether they tested positive for gestational diabetes during the standard testing process which typically occurs at 24-28 weeks gestation. The data will then be analyzed to estimate the sensitivity, specificity, positive and negative predictive values of the first trimester GGT and uric acid tests. The GGT and uric acid levels which maximize the area under the receiver-operator characteristic curve will be identified.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First Trimester Prenatal Visit | – | Diagnostic Test: GGT/Uric AcidWomen attending an initial first trimester prenatal visit who will be undergoing a standard blood draw. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women between > 9 weeks and < 14 and 0 weeks gestation presenting to the OB clinic for prenatal care
Key inclusion criteria (1 listed)
- Pregnant women between > 9 weeks and < 14.0 weeks gestation
Key exclusion criteria (7 listed)
- Known history of or current diagnosis of type I or type II diabetes mellitus
- Known liver disease
- Known kidney disease
- Known history of or current diagnosis of gout
- Known history of alcoholism or current alcohol use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GGT/Uric AcidStandard laboratory blood testing for GGT and uric acid levels. | Diagnostic test | First Trimester Prenatal Visit |
Primary outcome
Proportion of patients diagnosed with gestational diabetes mellitus
Time frame: 24-28 weeks
Diagnosis of gestational diabetes mellitus (GDM) via oral glucose tolerance testing (Carpenter and Coustan criteria)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data with others. Study data may be requested from the sponsor or investigator.
Related trials for Gestational Diabetes
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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.
James Dombroski, MD study chair
Mount Carmel Health System
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, run by Mount Carmel Health System 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 1 inclusion and 7 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: withdrawn, as of the sponsor's last update on 6 Jun 2025. 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 was withdrawn before enrolling participants, so there are no results.
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?
Proportion of patients diagnosed with gestational diabetes mellitus (time frame: 24-28 weeks). 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 6 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.