The Effect of Curcumin on the Development of Prednisolone-induced Hepatic Insulin Resistance
NCT04315350 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2022-04-12
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
Interventions
- DRUG
-
Curcumin Liposome
Curcumin is given together with prednisolone
- DRUG
-
Prednisolone
Prednisolone is given together with curcumin-placebo
- DRUG
-
Placebos
Prednisolone-placebo is given together with curcumin-placebo
Sponsors & Collaborators
-
University Hospital, Gentofte, Copenhagen
lead OTHER
Principal Investigators
-
Filip K Knop, Professor · Gentofte university hospital, Hellerup, Denmark
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-12-01
- Primary Completion
- 2021-06-07
- Completion
- 2021-06-11
Countries
- Denmark
Study Locations
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