Effects of obeticholic acid on hepatic fatty acid/triglyceride metabolism and hepatobiliary detoxification/elimination in morbidly obese and gallstone patients. - OCABSGS

Conditions: Fatty liver disease, morbid obesity, gallstone disease
MedDRA version: 14.1Level: LLTClassification code 10029530Term: Non-alcoholic fatty liverSystem Organ Class: 10019805 - Hepatobiliary disorders

Registration Number: EUCTR2011-000813-37-SE

Lead Sponsor: Sahlgrenska Academy

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Age20 to 65 years;
in the obesity group: BMI =35 kg/m2
in the gallstone group: symptomatic, ultrasound verified gallstone disease
SexMales, pre-, and post-menopausal females
DiagnosisPatients eligible to laparoscopic bariatric and gallstone surgery, respectively
ConsentPatients should have given their written consent to participate in this study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

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 (a subject who is euthyroid on a stable replacement dose of thyroid hormone is
acceptable provided the TSH is within normal range).

Other serious disease, including depressive disorders treated by medication

Patients who will not comply with the protocol.

Pregnancy. Women in childbearing age must adhere to secure anticonception

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Secondary trial objectives are to determine whether<br>(i) INT-747 changes in serum cholesterol and triglycerides<br>(ii) INT-747 changes in energy consumption;Primary end point(s): - relative changes in markers for insulin resistance<br>- relative changes in FA and TG<br>- relative changes in hepatic and adipose tissue lipase expression and activity<br>- relative changes in hepatic apical transport proteins ABCG5/8, BSEP, MDR3, MRP2<br>- relative changes in hepatic ER stress markers<br>;Main Objective: Main trial objectives are to determine whether<br>(i)INT-747 (25 mg/day) improves insulin resistance in patients with non-alcoholic fatty liver disease (NAFLD)<br>(iii)INT-747 alters hepatic and/or white adipose tissue (WAT) lipase activity and fatty acid/triglyceride (FA/TG) content in NAFLD<br>(iv)INT-747 improves hepatobiliary transporter expression in NAFLD and gallstone disease<br>(v)INT-747 improves biliary lipid profiles towards lower cholesterol saturation<br>

Secondary Outcome Measures