Status:
COMPLETED
The Effect of Curcumin on Liver Fat Content in Obese Subjects
Lead Sponsor:
Steno Diabetes Center Copenhagen
Collaborating Sponsors:
University of Copenhagen
University of Aarhus
Conditions:
Non-Alcoholic Fatty Liver Disease
Insulin Resistance
Eligibility:
MALE
20+ years
Phase:
NA
Brief Summary
The majority of obese have non-alcoholic fatty liver disease (NALFD). Currently, no pharmacological agents are licenced for the prevention or treatment of NAFLD, and weight loss, notoriously difficult...
Detailed Description
The prevalence of obesity is increasing worldwide. Obesity and its associated complications represent an enormous burden for obese individuals, their families, healthcare systems and societies. Non-al...
Eligibility Criteria
Inclusion
- BMI \>30.0 kg/m2
- Haemoglobin ≥7.5 mmol/l
- Written informed consent
- If the subject is known with diet treated diabetes, HbA1c has to be \< 48 mmol/mol.
- If the subject is not known diabetes, HbA1c can be \<53 mmol/mol
- Two of the following four parameters:
- Steatosis on Fibro scan with M-probe or XL-probe (S\>=1)
- Waist circumference \>94 cm
- HbA1c\>48 mmol/mol
- FLI score \>60% (see enclosure 2 "FLI score")
- Diagnosis of steatosis on liver biopsy, ultrasound or MR-scan within the last three years and no weight loss or treatment of steatosis since diagnosis. If this inclusion criterion is fulfilled, the BMI criterion written above will not be \> 30 kg/m2, but \> 27 kg/m2
Exclusion
- Use of glucose-lowering drugs, lipid-lowering drugs, warfarin, clopidogrel or non-vitamin K oral anticoagulants
- Treatment with drugs with potential steatogenic side-effects within three months prior to inclusion (e.g. tetracycline, valproic acid, systemic glucocorticoids, amiodarone, tamoxifen and methotrexate)
- Known viral, inherited or alcoholic liver disease, or any other condition known to affect the liver (e.g. coeliac disease, Wilsons disease, cystic fibrosis, alpha-1 anti-trypsin deficiency)
- Positive result of blood test for viral hepatitis markers
- Intake of more than 21 units of alcohol per week, or earlier alcohol abuse
- Frequent use of anti-inflammatory drugs
- Nephropathy (eGFR \< 60 ml/min/1.73 m² and/or urine albumin \> 20 mg/L)
- In a weight management program, or planning to change life style, alcohol habits or eating habits during the study
- Known allergy to curcumin/turmeric
- Claustrophobia
- Implanted metal objects contraindicative of MRS
- Any condition(s) or clinical or biochemical signs that the investigator think would interfere with trial participation or with the safety of the subject
- Any regular drug treatment that cannot be discontinued for minimum 18 hours
Key Trial Info
Start Date :
March 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2020
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03864783
Start Date
March 5 2019
End Date
December 16 2020
Last Update
February 3 2021
Active Locations (1)
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1
Center for Clinical Metabolic Research
Hellerup, Denmark, 2900