| Trial ID: | L0018 |
| Source ID: | NCT04330326
|
| Associated Drug: |
Metabolic Cofactor Supplementation
|
| Title: |
Metabolic Cofactor Supplementation in Obese Patients With Non-Alcoholic Fatty Liver Disease
|
| Acronym: |
NAFLD
|
| Status: |
Unknown status
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic Fatty Liver Disease (NAFLD)
|
| Interventions: |
Drug: Metabolic Cofactor Supplementation|Drug: Sorbitol
|
| Outcome Measures: |
Magnetic Resonance Spectroscopy (MRS) Measurement|Change in body weight from baseline|ECG Measurement|Change in Blood Pressure from baseline|Change in waist and hip circumference from baseline|Change of complete blood count (number of blood cells) from baseline|Change of complete blood count (hemoglobin) from baseline|Changes in kidney function tests (creatinine, urea, uric acid) from baseline|Changes in kidney function tests (sodium, potassium) from baseline|Changes in liver function tests [Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gamma-glutamyl transferase (GGT), Alkaline phosphatase (ALP)] from baseline|Changes in liver function tests (Total Bilirubin, and Albumin) from baseline|Changes in creatinine kinase (CK) level from baseline|Changes in blood lipid levels (total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL-C), high density lipoprotein (HDL-C)) from baseline|Changes in blood glucose levels from baseline|Change in blood insulin level from baseline|Change in thyroid-stimulating hormone (TSH) level from baseline|Microbiota analysis|Monitoring of adverse events
|
| Sponsor/Collaborators: |
ScandiBio Therapeutics AB|Ko?? University|Ko?? University Hospital|G??teborg University|Sahlgrenska University Hospital, Sweden|KTH Royal Institute of Technology|University of Helsinki|Helsinki University Central Hospital|Monitor CRO
|
| Gender: |
All
|
| Age: |
18 Years to 70 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
45
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
|
| Start Date: |
July 20, 2019
|
| Completion Date: |
September 2020
|
| Results First Posted: |
--
|
| Last Update Posted: |
April 1, 2020
|
| Locations: |
Ko?? University Hospital, Istanbul, Turkey
|
| URL: |
https://ClinicalTrials.gov/show/NCT04330326
|
