Non Alcoholic Fatty Liver Disease
Conditions
Brief summary
The purpose of the study is to evaluate the efficacy and safety of Niacinamide supplementation on clinical outcome of fatty liver patients having type II DM through measurement of the following before and after Niacinamide administration: Liver enzymes, Lipid profie, HOMA-IR, Oxidative stress markers and endothelial dysfunction marker. Fibroscan with CAP will be done at baseline and at the end of the trial. Also, Evaluation of quality of life of patients before and after Niacinamide administration using Chronic Liver Disease questionnaire.
Interventions
DIETARY_SUPPLEMENTNiacinamide Oral Tablet
Nature's Life Niacinamide 1000 mg
DRUGAntidiabetic
Metformin or Sulphonylurea
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 1\. Male or female outpatients age 18 to 70 years old. 2. The diagnosis of NAFLD will be established according to the appearance of fatty liver on US or elevated liver enzymes (\>1.5 times normal level).
Exclusion criteria
* 1\. History of alcohol abuse (as defined by an average daily consumption of alcohol \> 30 g/day in men and \> 20 g/day in women). 2\. Cirrhotic patients. * Fibroscan result \> 12Kpa or as * predicted from FIB 4 score \> 3.25 FIB-4 = age (yr) \* AST (IU/L)/platelet count (109/L) \* ALT1/2 (IU/L) 3. Hyper / hypoparathyroidism. 4. Cancer. 5. Viral hepatitis. 6. Biliary disease. 7. Autoimmune hepatitis 8. Other causes of liver disease (hemochromatosis, Wilson's disease). 9. Participants who took antibiotics, probiotic supplements and/or hepatotoxic medicines (NSAIDs, Amiodarone and methotrexate) within 6 months before the start of the study and during the study. 10\. Ascetic patients and congestive heart failure patients will be excluded due to unreliability of Fibroscan results in them. 11\. Pregnancy and lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adiponectin mesurement | 3 months | Endothelial dysfunction |
| Steatosis using Fibroscan with CAP | 3 months | using Fibroscan with CAP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HOMA-IR | 3 months | Insulin resistance |
| LDL, cholesterol | 3 months | Lipid markers |
| ALT, AST | 3 months | Liver enzymes |
| Malondialdehyde | 3 monthes | Oxidative stress marker |
Other
| Measure | Time frame | Description |
|---|---|---|
| Chronic Liver Disease Questionnaire | 3 months | quality of measurement |
Countries
Egypt
Outcome results
None listed