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GGT and Uric Acid to Predict Gestational Diabetes Mellitus

A legfontosabb adatok

Ki végzi
Mount Carmel Health System
Hol
Columbus (Egyesült Államok)A helyszín megnézése
Azonosító
Állapot
Visszavonva
Kezdés
2021. jún. 21.
Befejezés
2024. dec. 31.
A vizsgálat típusa
Megfigyeléses
A vizsgált kezelések
  • GGT/Uric Acid
A regiszteradat frissítve
2025. június 6.
Miért állt le
Principal Investigator left the institution.

Ki vehet részt

Életkor
18 év felett
Nem
Csak nők
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 8 feltétel megnézéseKevesebb

Ki vehet részt

  • Pregnant women between > 9 weeks and < 14.0 weeks gestation

Ki nem vehet részt

  • 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
  • < 18 years of age
  • Multiple gestation

Helyszínek itt: Egyesült Államok

  • Mount Carmel Health SystemColumbus, Egyesült Államok

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A teljes eredeti leírásKevesebb

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.

A vizsgálat csoportja

  • First Trimester Prenatal Visit

    Women attending an initial first trimester prenatal visit who will be undergoing a standard blood draw.

    Kezelés: GGT/Uric Acid

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Association of Elevated Serum Gamma Glutamyl Transferase (GGT) and Uric Acid at 9-14 Weeks Gestation With the Development of Gestational Diabetes Mellitus (GDM)
A regiszteradat frissítve
2025. június 6.