GGT and Uric Acid to Predict Gestational Diabetes Mellitus

NCT04956094 | Withdrawn

• 1 other identifier: 210412-1
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

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)

  24-28 weeks

Study Arms (1)

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

GGT/Uric Acid DIAGNOSTIC_TEST

Standard laboratory blood testing for GGT and uric acid levels.

First Trimester Prenatal Visit

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant Females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Carmel Health System: lead
• Mount Carmel Foundation: collaborator

Study Sites (1)

Mount Carmel Health System

Columbus, Ohio, 43213, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational; Hypersensitivity

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Immune System Diseases

Study Officials

• James Dombroski, MD

  Mount Carmel Health System

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 9, 2021
• Study Start: June 21, 2021
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: June 6, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)