- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01855386
The Role of Non-Alcoholic Fatty Liver Disease in Gestational Diabetes
Non-Alcoholic Fatty Liver Disease in Gestational Diabetes - An Opportunity for Prevention of Type 2 Diabetes Mellitus?
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
A liver ultrasound will be completed during the last trimester of pregnancy along with a questionnaire. The questionnaire includes baseline maternal characteristics, age, race, ethnicity, parity, blood pressure, pulse, medications, activity level, sociodemographic and behavioral risk factors, pregravid BMI, previous obstetric history, medical and family history.
The subject will come in person to clinic two times after the subject has had her baby (at 6 weeks postpartum, and at 6 months postpartum).
The subject will give blood samples during the 6 weeks postpartum visit and 6 months postpartum visit, and an Oral Glucose Tolerance Test will be done at these visits. Blood samples will be drawn by putting a small needle or IV catheter (a small plastic tube) into a vein in the subject's arm. Blood samples will be obtained at timed intervals both before and after the subject is given a glucose beverage to drink, to see how well the subject's body deals with sugar in the blood over time. The total amount of blood to be drawn for each Oral Glucose Tolerance Test and research blood work will be approximately 90 ml (about 6 tablespoons). The total volume of blood taken over the course of the study for each subject will be approximately 180 ml (about 12 tablespoons).
The subject will have their blood pressure measured with a blood pressure cuff during each clinic visit. The height, weight and pulse rate will also be measured. This will take about five minutes.
The subject will have an ultrasound of her liver at the 6 week postpartum visit and 6 month postpartum visit. This will take about 30 to 60 minutes each time.
The investigator's study coordinator will call the subject to do a questionnaire over the phone at 3 months after the subject has had the baby. During the phone call, the study coordinator will ask the subject how the baby is being fed. The study coordinator will also update information about development of any new medical problems and medications the subject's doctor might have started, activity levels, and health habits. Subjects will be asked questionnaires to update this information during their 6 week postpartum and 6 month postpartum clinic visits as well.
The subject's understanding and approval of these procedures is required if she is to participate in this study.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Florida
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Gainesville, Florida, Stati Uniti, 32608
- Shands Medical Plaza
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
- a pregnant female
- age between 18-50 years.
Descrizione
Inclusion Criteria:
- a pregnant female
- age between 18-50 years.
Exclusion Criteria:
- pregravid diabetes mellitus
- inability to understand and speak English
- inability to provide consent
- plans to relocate out of the area within 12 months postpartum
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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Subjects with Gestational Diabetes
Subjects with a history of Gestational Diabetes will provide blood samples, blood pressure measured with a blood pressure cuff, pulse, height, weight, and ultrasound of the liver at the 6 week postpartum and 6 month postpartum visits.
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Subjects with a history of Gestational Diabetes will provide blood samples, blood pressure measured with a blood pressure cuff, pulse, height, weight, and ultrasound of the liver at the 6 week postpartum and 6 month postpartum visits.
Altri nomi:
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Controls without Gestational Diabetes
Matched control subjects without Gestational Diabetes will provide blood samples, blood pressure measured with a blood pressure cuff, pulse, height, weight, and ultrasound of the liver at the 6 week postpartum and 6 month postpartum visits.
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Matched control subjects without gestational diabetes will provide blood samples, blood pressure measured with a blood pressure cuff, pulse, height, weight, and ultrasound of the liver at the 6 week postpartum and 6 month postpartum visits.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of patients with NAFLD and gestational diabetes.
Lasso di tempo: 6 months
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Patients with gestational diabetes will be screened for fatty liver by ultrasound to estimate the prevalence of NAFLD in this population.
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6 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Insulin sensitivity expressed as the Matsuda Index, measured during an oral glucose tolerance test (OGTT).
Lasso di tempo: At 6 weeks and 6 months after delivery
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Patients will undergo an OGTT at 6 weeks and 6 months after delivery to measure their insulin sensitivity (which will be expressed as Matsuda Index).
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At 6 weeks and 6 months after delivery
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Maryam Sattari, MD, University of Florida
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Disturbi del metabolismo del glucosio
- Malattie metaboliche
- Malattie del sistema endocrino
- Complicazioni della gravidanza
- Malattie del fegato
- Diabete mellito
- Fegato grasso
- Malattia del fegato grasso non alcolica
- Diabete, gestazionale
- Gravidanza nei diabetici
- Ematinici
- Estratti di fegato
Altri numeri di identificazione dello studio
- IRB201600437
- 375-2012 (Altro identificatore: University of Florida)
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Subjects with Gestational Diabetes
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University of ArkansasNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Northwestern... e altri collaboratoriCompletato