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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02532335 |
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Date of registration:
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21/08/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Obeticholic Acid in Morbidly Obese Patients and Healthy Volunteers
OCAPUSH |
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Scientific title:
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Study of the Effects of Obeticholic Acid on Farnesoid X Receptor Expression in Jejunum and on Gut Microbiota in Morbidly Obese Patients and Healthy Volunteers |
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Date of first enrolment:
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August 2015 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02532335 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 1
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Hanns-Ulrich Marschall |
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Address:
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Telephone:
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+4670774073 |
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Email:
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hanns-ulrich.marschall@gu.se |
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Affiliation:
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Name:
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Hanns-Ulrich Marschall, MD, PhD, MSc |
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Address:
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Telephone:
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+46708774073 |
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Email:
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hanns-ulrich.marschall@gu.se |
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Affiliation:
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Name:
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Hanns-Ulrich Marschall |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sahlgrenska University Hospital, Sweden |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Morbid obesity awaiting gastric bypass surgery, =35 kg/m2
Male subjects, pre-, and post-menopausal female subjects
Women of childbearing potential can only be included if a safe and reliable contraception
is used, e.g., oral contraceptives
Patients eligible to laparoscopic bariatric surgery
Patients must give their signed and dated written consent to participate in this study
based on written information of all pertinent aspects of the trial provided at least 24
hours before undertaking any trial related activity.
Exclusion Criteria:
Chronic liver disease other than NAFLD (viral hepatitis, autoimmune liver disease,
hemochromatosis, homozygous alpha1-antitrypsin deficiency and Wilson disease)
Previous gastric or small bowel surgery
Inflammatory bowel disease
Uncontrolled diabetes mellitus (fasting blood glucose >6.7 mmol/L), hypothyroidism or
hyperthyroidism, or other significant endocrine disease.
Pregnancy. A urine pregnancy test will be performed the day before start of medication.
Women of childbearing potential can only be included if a safe and reliable contraception
is used, e.g., oral contraceptives.
Elevations of transaminases (ALAT/ASAT) or alkaline phosphatase or bilirubin above 2xULN
(upper limit of normal) the day before start of medication.
Other serious disease, including depressive disorders treated by medication
Patients who will not comply with the protocol.
Hypothyroidism, unless the subject is clinically euthyroid, receiving a stable dose thyroid
hormone replacement therapy and serum TSH is within the normal range.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Obesity
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Intervention(s)
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Drug: Obeticholic acid placebo
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Drug: Obeticholic acid
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Primary Outcome(s)
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ChIP-assay in biopsies as a measure of Activation of FXR-dependent genes in small intestine
[Time Frame: Three weeks]
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Secondary Outcome(s)
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Shot-gun metagenomics as a measure of Impact of FXR activation on gut microbiota
[Time Frame: Three weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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