GGT and Uric Acid to Predict Gestational Diabetes Mellitus

NCT ID: NCT04956094

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-21
• Study Completion Date: 2024-12-31

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.

Conditions

Gestational Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

First Trimester Prenatal Visit

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

GGT/Uric Acid

Intervention Type: DIAGNOSTIC_TEST

Standard laboratory blood testing for GGT and uric acid levels.

Interventions

GGT/Uric Acid

Standard laboratory blood testing for GGT and uric acid levels.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mount Carmel Foundation

UNKNOWN

Sponsor Role: collaborator

Mount Carmel Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Dombroski, MD

Role: STUDY_CHAIR

Mount Carmel Health System

Locations

Mount Carmel Health System

Columbus, Ohio, United States

Countries

United States

Other Identifiers

210412-1

Identifier Type: -

Identifier Source: org_study_id