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NCT04956094: GGTUAGDM
GGT and Uric Acid to Predict Gestational Diabetes Mellitus
trial testing GGT/Uric Acid in Gestational Diabetes. Withdrawn.
30 June 2024
Quick facts
| Lead sponsor | Mount Carmel Health System |
|---|---|
| Status | Withdrawn |
| Study type | OBSERVATIONAL |
| Start date | 21 June 2021 |
| Primary completion | 30 June 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- GGT/Uric Acid
Conditions studied
- Gestational Diabetes — all drugs for Gestational Diabetes →
Sponsor
Mount Carmel Health System — full company profile →
Who can join
18 and older, female only, with Gestational Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04956094
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Other Mount Carmel Health System trials
Trials by the same sponsor.
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- NCT04900883 — Nurse Perspectives Regarding Use of the Labor Mirror · completed
- NCT03284437 — Pilot Study of Early Cognitive Training in the Intensive Care Unit · NA · withdrawn
- NCT03536897 — IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry · recruiting
- NCT03319498 — Postpartum Urinary Retention With Essential Oils (PURE) · NA · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04956094 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mount Carmel Health System
- Last refreshed: 6 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04956094.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing