Clinical trial NCT04956094: GGT and Uric Acid to Predict Gestational Diabetes Mellitus
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)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Gestational Diabetes
Keywords: Pregnancy
Screening
Gamma Glutamyl Transferase
Serum Uric Acid
Sensitivity
Specificity
Predictive Value
Lead sponsor: Mount Carmel Health System
Sponsor class: OTHER
Collaborators: name: Mount Carmel Foundation
First posted: 2021-07-09
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


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

Primary outcomes:
measure: Proportion of patients diagnosed with gestational diabetes mellitus
timeFrame: 24-28 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Mount Carmel Health System
state: Ohio
Study officials:
affiliation: Mount Carmel Health System
name: James Dombroski, MD
role: STUDY_CHAIR
References: