The Effect of Curcumin on the Development of Prednisolone-induced Hepatic Insulin Resistance

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Male

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 short-term oral glucocorticoid (prednisolone) administration in overweight and obese participants. As a secondary endpoint it will be investigated if prednisolone administration induce or worsen the degree of NAFLD in overweight or obese participants using magnetic resonance (MR) spectroscopy (MRS), and if curcumin can ameliorate this effect. Also, the possible anti-inflammatory effect of curcumin will be elucidated as a range of inflammatory markers before and after intervention will be measured. Thus, prednisolone treatment is used as a model of development of pre-diabetes.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Gentofte, Copenhagen
• Treatments: Curcumin; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• 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 Criteria:

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.