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GGT and Uric Acid to Predict Gestational Diabetes Mellitus

Association of Elevated Serum Gamma Glutamyl Transferase (GGT) and Uric Acid at 9-14 Weeks Gestation With the Development of Gestational Diabetes Mellitus (GDM)

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04956094
Acronym
GGTUAGDM
Enrollment
0
Registered
2021-07-09
Start date
2021-06-21
Completion date
2024-12-31
Last updated
2025-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes

Keywords

Pregnancy, Screening, Gamma Glutamyl Transferase, Serum Uric Acid, Sensitivity, Specificity, Predictive Value

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTGGT/Uric Acid

Standard laboratory blood testing for GGT and uric acid levels.

Sponsors

Mount Carmel Foundation
CollaboratorUNKNOWN
Mount Carmel Health System
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Pregnant women between \> 9 weeks and \< 14.0 weeks gestation

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients diagnosed with gestational diabetes mellitus24-28 weeksDiagnosis of gestational diabetes mellitus (GDM) via oral glucose tolerance testing (Carpenter and Coustan criteria)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026