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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
Sponsor:
Collaborator:
Mount Carmel Foundation
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Gestational Diabetes Diagnostic Test: GGT/Uric Acid

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Uric Acid

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant Females
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
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

Information from the National Library of Medicine

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


Contacts
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Contact: Lynn Shaffer, PhD 614-663-4641 Lynn.Shaffer@mchs.com
Contact: Cameron Rink, PhD 614-546-4518 Cameron.Rink@mchs.com

Locations
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United States, Ohio
Mount Carmel Health System Recruiting
Columbus, Ohio, United States, 43213
Contact: Lynn Shaffer, PhD    614-663-4641    lynn.shaffer@mchs.com   
Contact: Minden Collamore, DO    380-898-8808    minden.collamore001@mchs.com   
Principal Investigator: Collamore Minden, DO         
Sponsors and Collaborators
Mount Carmel Health System
Mount Carmel Foundation
Investigators
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Study Chair: James Dombroski, MD Mount Carmel Health System
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Responsible Party: Mount Carmel Health System
ClinicalTrials.gov Identifier: NCT04956094    
Other Study ID Numbers: 210412-1
First Posted: July 9, 2021    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data with others. Study data may be requested from the sponsor or investigator.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mount Carmel Health System:
Pregnancy
Screening
Gamma Glutamyl Transferase
Serum Uric Acid
Sensitivity
Specificity
Predictive Value
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Uric Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs