GGT and Uric Acid to Predict Gestational Diabetes Mellitus

Gestational Diabetes Clinical Trial

— GGTUAGDM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04956094
• Other study ID #: 210412-1
• Status: Recruiting
• Start date: June 21, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Mount Carmel Health System
• Contact: Lynn Shaffer, PhD
• Phone: 614-663-4641
• Email: Lynn.Shaffer[@]mchs.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Diagnostic Test:
• GGT/Uric Acid
Standard laboratory blood testing for GGT and uric acid levels.

Locations

Country	Name	City	State
United States	Mount Carmel Health System	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Mount Carmel Health System	Mount Carmel Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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