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

NCT04315350 | Terminated

• 1 other identifier: H-19017550
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Insulin Resistance; Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• HOMA-IR

  homeostatic model assessment of insulin resistance is calculated before and after intervention

  12-14 days

Secondary Outcomes (67)

• steatosis

  12-20 days

• liver stiffness

  12-14 days

• concentration of alanine transaminase

  12-14 days

• concentration of aspartate transaminase

  12-14 days

• concentration of creatine kinase

  12-14 days

Study Arms (3)

Curcumin

EXPERIMENTAL

Participant receives both curcumin and prednisolone. Curcumin for 11 days, prednisolone for 10 days. Curcumin: 2 tablets (each contains 100 mg curcumin) twice daily. Prednisolon: 50 mg (capsule) every morning

Drug: Curcumin Liposome

Prednisolon

OTHER

Participant receives prednisolone and curcumin-placebo. Curcumin-placebo for 11 days, prednisolone for 10 days. Curcumin-placebo: 2 tablets twice daily. Prednisolon: 50 mg (capsule) every morning

Drug: Prednisolone

Placebo

PLACEBO COMPARATOR

Participant receives prednisolone.placebo and curcumin-placebo. Curcumin-placebo for 11 days, prednisolone-placebo for 10 days. Curcumin-placebo: 2 tablets twice daily. Prednisolon-placebo: One capsule every morning.

Drug: Placebos

Interventions

Curcumin Liposome DRUG

Curcumin is given together with prednisolone

Curcumin

Prednisolone DRUG

Prednisolone is given together with curcumin-placebo

Prednisolon

Placebos DRUG

Prednisolone-placebo is given together with curcumin-placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only males are included
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Use of glucose-lowering drugs, lipid-lowering drugs, warfarin, clopidogrel or non-vitamin K anti-coagulants
• 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.

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (1)

Center for Clinical Metabolic Research

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Insulin Resistance; Non-alcoholic Fatty Liver Disease

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Filip K Knop, Professor

  Gentofte university hospital, Hellerup, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, primary investigator

Model Details: After study day 1, participants are randomized (1:1:1) to one of three treatments: 1) Prednisolon and Curcumin, 2) Prednisolon and placebo or 3) Placebo and placebo.

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: March 19, 2020
• Study Start: December 1, 2019
• Primary Completion: June 7, 2021
• Study Completion: June 11, 2021
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

DK (1)