- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03475849
Effects of Gastric Bypass Surgery on Bile Acid Homeostasis
The purpose of this study is to determine whether the bile acid circulation is changed after gastric bypass surgery. Further, to account for how the changed anatomy of the gut influences how the bile acid and food is mixed in the gut and how this is associated with the changes in gut hormone release after the surgery.
Our hypothesis is that bile acid reabsorption from the gut is increased as animal models suggest so and bile acid blood concentration increases after surgery.
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Copenhagen
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Hvidovre, Copenhagen, Danmark, DK-2650
- Department of Endocrinology at Hvidovre University Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Age between 25 and 65 years
- For patients: uncomplicated Roux-en-Y Gastric Bypass surgery more than 12 months before study initiation
- For controls: Age, BMI and gender matched with patient group
Exclusion Criteria:
- Previous removal of gall bladder or other abdominal surgeries except appendectomy (and gastric bypass surgery for patient group)
- Known liver disease or thyroid disease requiring antithyroid medication
- Chronic gastrointestinal symptoms
- Any chronic disease interfering with, or susceptive of interfering with appetite or gastrointestinal function
- Any medication interfering with, or susceptive of interfering with appetite or gastrointestinal function
- Smoking within the last month
- Alcohol consumption above 168 grams per week
- Currently pregnant or breast-feeding
- Anaemia with haemoglobin <6,5 mmol/L (<117 mg/dl)
- Loss or gain of more than 3 kg within the last 3 months
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Case-Control
- Tidsperspektiver: Tverrsnitt
Kohorter og intervensjoner
Gruppe / Kohort |
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RYGB subjects
Morbidly obese patients who has undergone an uncomplicated gastric bypass surgery more than 12 months before study start.
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Control subjects
Age, sex and BMI-matched healthy controls
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SG subjects
Morbidly obese patients who has undergone an uncomplicated sleeve gastrectomy surgery more than 12 months before study start.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Differences in time from food intake to mix of food in the gut with bile acid between patients and controls
Tidsramme: Patients: >12 months after Gastric Bypass Surgery
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Patients: >12 months after Gastric Bypass Surgery
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Percentage of orally ingested exogenic bile acid that is retained in the body after 7 days
Tidsramme: Patients: >12 months after Gastric Bypass Surgery
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Patients: >12 months after Gastric Bypass Surgery
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GAL-CAJ-16
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