Status:
TERMINATED
The Effect of Curcumin on the Development of Prednisolone-induced Hepatic Insulin Resistance
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Conditions:
Insulin Resistance
Non-Alcoholic Fatty Liver Disease
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The aim of this study is to investigate whether ingestion of curcumin will prevent hepatic insulin resistance (assessed by homeostatic model assessment of insulin resistance (HOMA-IR)) induced by shor...
Detailed Description
AIMS OF STUDY The aim of this study is to investigate whether ingestion of curcumin will prevent hepatic insulin resistance (assessed by homeostatic model assessment of insulin resistance (HOMA-IR)) i...
Eligibility Criteria
Inclusion
- Body mass index (BMI) \>24.9 kg/m2, If participant is included during COVID19-pandemic, maximum BMI is 32 kg/m2
- Haemoglobin ≥7.5 mmol/l
- Written informed consent
Exclusion
- If the participant is screened during COVID19, extra exclusion criteria is age\>59 years.
- If the participant is screened during COVID19-pandemic, following exclusion criteria is also applicable: 1) Diagnosed with asthma requiring medication or having uncontrolled asthma. 2) Beeing a current smoker. 3) diagnosed with hypertension. 4) having a job or engaging in daily activities, where it is not possible to adhere to the required distance of one meter to other people, judged by the investigator. 5) bA1c above 42 mmol/mol at screening.
- Use of glucose-lowering drugs, lipid-lowering drugs, warfarin, clopidogrel or non-vitamin K anti-coagulants
- Frequent use of anti-inflammatory drugs the last two months prior to inclusion, judged by the investigator
- Treatment with drugs with potential steatogenic side-effects within two months prior to inclusion
- Use of medication known to interact with prednisolone
- Use of curcumin-containing food supplements or other natural products that could cause confounding as evaluated by investigator
- Any regular drug treatment that cannot be discontinued for minimum 18 hours
- Previous diagnosis of T2D
- Diabetes (HbA1c ≥ 48 mmol/mol) found at screening
- Known viral, inherited or alcoholic liver disease, or any other condition known to affect liver
- Intake of more than 21 units of alcohol per week
- 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 course of the study
- Implanted metal objects contraindicative of MRS Claustrophobia
- Any condition that the investigator think would interfere with trial participation or with the safety of the participant.
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04315350
Start Date
December 1 2019
End Date
June 11 2021
Last Update
April 12 2022
Active Locations (1)
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1
Center for Clinical Metabolic Research
Hellerup, Denmark, 2900