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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Niacinamide group | Experimental | Niacinamide oral tablets as Nature's Life 1000 mg tablets once daily for 3 months diabetes management including metformin or Sulphonylurea |
|
| Control group | Active Comparator | diabetes management including metformin or Sulphonylurea |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niacinamide Oral Tablet | Dietary Supplement | Nature's Life Niacinamide 1000 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Steatosis using Fibroscan with CAP | using Fibroscan with CAP | 3 months |
| Adiponectin mesurement | Endothelial dysfunction | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Malondialdehyde | Oxidative stress marker | 3 monthes |
| HOMA-IR | Insulin resistance | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic Liver Disease Questionnaire | quality of measurement | 3 months |
Inclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AlZahraa hospital | Cairo | 02 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35222903 | Derived | El-Kady RR, Ali AK, El Wakeel LM, Sabri NA, Shawki MA. Nicotinamide supplementation in diabetic nonalcoholic fatty liver disease patients: randomized controlled trial. Ther Adv Chronic Dis. 2022 Feb 23;13:20406223221077958. doi: 10.1177/20406223221077958. eCollection 2022. |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D009536 | Niacinamide |
| D007004 | Hypoglycemic Agents |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| Antidiabetic | Drug | Metformin or Sulphonylurea |
|
| ALT, AST | Liver enzymes | 3 months |
| LDL, cholesterol | Lipid markers | 3 months |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |