GGT and Uric Acid to Predict Gestational Diabetes Mellitus (GGTUAGDM)
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|ClinicalTrials.gov Identifier: NCT04956094|
Recruitment Status : Recruiting
First Posted : July 9, 2021
Last Update Posted : July 16, 2021
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.
|Condition or disease||Intervention/treatment|
|Gestational Diabetes||Diagnostic Test: GGT/Uric Acid|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|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)|
|Actual Study Start Date :||June 21, 2021|
|Estimated Primary Completion Date :||June 30, 2023|
|Estimated Study Completion Date :||December 31, 2023|
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
Standard laboratory blood testing for GGT and uric acid levels.
- Proportion of patients diagnosed with gestational diabetes mellitus [ Time Frame: 24-28 weeks ]Diagnosis of gestational diabetes mellitus (GDM) via oral glucose tolerance testing (Carpenter and Coustan criteria)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04956094
|Contact: Lynn Shaffer, PhD||614-663-4641||Lynn.Shaffer@mchs.com|
|Contact: Cameron Rink, PhD||614-546-4518||Cameron.Rink@mchs.com|
|United States, Ohio|
|Mount Carmel Health System||Recruiting|
|Columbus, Ohio, United States, 43213|
|Contact: Lynn Shaffer, PhD 614-663-4641 email@example.com|
|Contact: Minden Collamore, DO 380-898-8808 firstname.lastname@example.org|
|Principal Investigator: Collamore Minden, DO|
|Study Chair:||James Dombroski, MD||Mount Carmel Health System|