GGT and Uric Acid to Predict Gestational Diabetes Mellitus

Active, not recruiting

• Conditions: Gestational Diabetes
• Interventions: Diagnostic Test: GGT/Uric Acid

• Registration Number: NCT04956094
• Lead Sponsor: Mount Carmel Health System

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-06-21
• Study First Submitted: 2021-06-30
• Study First Submitted QC: 2021-06-30
• Study First Posted: 2021-07-09
• Primary Completion: 2024-06-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
First Trimester Prenatal Visit	GGT/Uric Acid	Women attending an initial first trimester prenatal visit who will be undergoing a standard blood draw.

Primary Outcome Measures

Name	Time	Method
Proportion of patients diagnosed with gestational diabetes mellitus	24-28 weeks	Diagnosis of gestational diabetes mellitus (GDM) via oral glucose tolerance testing (Carpenter and Coustan criteria)

Trial Locations

Locations (1)

Mount Carmel Health System; 🇺🇸 Columbus, Ohio, United States