| Trial ID: | L0136 |
| Source ID: | NCT04315350
|
| Associated Drug: |
Curcumin
|
| Title: |
The Effect of Curcumin on the Development of Prednisolone-induced Hepatic Insulin Resistance
|
| Acronym: |
CURPRED
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Insulin Resistance|Non-Alcoholic Fatty Liver Disease
|
| Interventions: |
Drug: Curcumin Liposome|Drug: Prednisolone|Drug: Placebos
|
| Outcome Measures: |
HOMA-IR|steatosis|liver stiffness|concentration of alanine transaminase|concentration of aspartate transaminase|concentration of creatine kinase|glucagon levels under oral glucose tolerance test|concentration of amino acids under oral glucose tolerance test|urea concentration in plasma|urea concentration in urin|urea production|concentration of gamma glutamyl transferase|concentration of blood lipids|gut hormone concentration during oral glucose tolerance test|concentration of inflammation markers (interleukines and high sensitivity CRP and TNF alpha)|concentration of serum biomarkers of non-alcoholic steatohepatitis|concentration of serum biomarkers of fibrosis in the liver|concentration of fasting glucose|concentration of glucose levels during oral glucose tolerance test|concentration of serum bone markers|concentration of fibroblast growth factors|Gut microbiota analysis (abundance)|Gut microbiota analysis (alpha and beta diversity)|Gut microbiota analysis (link to phenotype of interest)|Glucose measurement by continuous monitor|intra ocular eye pressure in both eyes|BOdy composition (fat, water, skeletal muscle mass, fat-free mass)|visceral fat tissue amount|subcutaneous fat tissue amount|Body weight|Body mass index|waist circumference|hip circumference|Questionnaire during oral glucose tolerance test every 30 minutes and ten minutes after ad libitum meal: How hungry do you feel? Range: I'm not hungry at all - I've never been more hungry|Questionnaire during oral glucose tolerance test every 30 minutes and ten minutes after ad libitum meal: How full do you feel? Range: I have a big hole in my stomach - I can not eat one single bite more|Questionnaire during oral glucose tolerance test every 30 minutes and ten minutes after ad libitum meal: How filled up do you feel? Range: Not filled up at all - totally filled up|Questionnaire during oral glucose tolerance test every 30 minutes and ten minutes after ad libitum meal: How much do you think you can eat? Range: nothing at all - really much|Questionnaire during oral glucose tolerance test every 30 minutes and ten minutes after ad libitum meal: How do you feel? Range: Really bad - really good|Questionnaire during oral glucose tolerance test every 30 minutes and ten minutes after ad libitum meal: do you feel nausious? Range: yes, very much - no, not at all|Questionnaire during oral glucose tolerance test every 30 minutes and ten minutes after ad libitum meal: How thirsty do you feel? Range: Not thirsty at all - very thirsty|Questionnaire during ad libitum meal: appearance of the meal: Range: Not appetizing - very appetizing|Questionnaire during ad libitum meal: Smell of the meal: Range: Not appetizing - very appetizing|Questionnaire during ad libitum meal: Taste of the meal: Range: Bad - Good|Questionnaire during ad libitum meal: Does the meal have unwanted taste? Range: no, not at all - yes, a lot|Questionnaire during ad libitum meal: How is the overall impression of the meal? Range: not appetizing - Very appetizing|Food consumption|systolic blood pressure|diastolic blood pressure|heart rate|resting energy expenditure (kcal/day) measured by inderect calorimetry|Evaluation of food consumption the day before test day. Participant will fill out diary of all foods and drinks consumed.|Questionnaire regarding fullness before bedtime the day before test day: how hungry were you before bed time? Range: Very hungry - not hungry at all|Evaluation of physical activity the day before test day. Participant will fill out diary of all physical activities including activity intensity.|concentration of c-peptide during oral glucose tolerance test|concentration of lactate dehydrogenase|concentration of free fatty acids during oral glucose tolerance test|concentration of alkaline phosphatase|concentration of albumin|concentration of insulin fasting|levels of insulin during oral glucose tolerance test|thromboelastography measurement.|concentration of von Willebrands Factor in plasma|concentration of protein C in plasma|concentration of protrombin in plasma|concentration of X-fib in plasma|concentration of PRO-C6 in plasma|concentration of d-dimer in plasma|concentration of fibrinogen in plasma
|
| Sponsor/Collaborators: |
University Hospital, Gentofte, Copenhagen
|
| Gender: |
Male
|
| Age: |
18 Years and older ?? (Adult, Older Adult)
|
| Phases: |
Not applicable
|
| Enrollment: |
36
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
|
| Start Date: |
December 1, 2019
|
| Completion Date: |
December 1, 2021
|
| Results First Posted: |
--
|
| Last Update Posted: |
October 8, 2021
|
| Locations: |
Center for Clinical Metabolic Research, Hellerup, Denmark
|
| URL: |
https://ClinicalTrials.gov/show/NCT04315350
|
