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WithdrawnNCT04956094GGTUAGDMUpdated Jun 6, 2025

GGT and Uric Acid to Predict Gestational Diabetes Mellitus

An observational study in Gestational Diabetes, sponsored by Mount Carmel Health System. Withdrawn at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-06.

Sponsored by Mount Carmel Health System · Observational

Why this study was withdrawn
Principal Investigator left the institution.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Gestational Diabetes

Keywords

  • Pregnancy
  • Screening
  • Gamma Glutamyl Transferase
  • Serum Uric Acid
  • Sensitivity
  • Specificity
  • Predictive Value
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pregnant women between > 9 weeks and \< 14 and 0 weeks gestation presenting to the OB clinic for prenatal care

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • First Trimester Prenatal Visit

    Women attending an initial first trimester prenatal visit who will be undergoing a standard blood draw.

    Diagnostic Test: GGT/Uric Acid

Interventions

  • Diagnostic testGGT/Uric Acid

    Standard laboratory blood testing for GGT and uric acid levels.

05

What researchers measure

Primary outcomes

  1. Proportion of patients diagnosed with gestational diabetes mellitus

    Diagnosis of gestational diabetes mellitus (GDM) via oral glucose tolerance testing (Carpenter and Coustan criteria)

    Time frame: 24-28 weeks

06

Study locations

1 site
  • Mount Carmel Health System
    Columbus, Ohio 43213, United States
07

References and documents

Individual participant data

Plan to share: No — There is no plan to share individual participant data with others. Study data may be requested from the sponsor or investigator.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04956094
Lead sponsor
Mount Carmel Health System
Collaborators
Mount Carmel Foundation
Responsible party
Sponsor
First posted
Jul 9, 2021
Start date
Jun 21, 2021
Primary completion
Jun 30, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jun 6, 2025

Study contacts

James Dombroski, MD
study chair · Mount Carmel Health System

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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