Type 2 Diabetes Nonalcoholic Fatty Liver Clinical Trial
| Verified date | April 2019 |
| Source | National Nutrition and Food Technology Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to investigate the effects of coffee main constituents (caffeine and chlorogenic acid) supplements on inflammatory, metabolic factors, hepatic steatosis and fibrosis in none- alcoholic fatty liver patients with type 2 diabetes. Two hundred patients with fatty liver and type 2 diabetes will be randomly assigned to one of four groups: group 1, caffeine (200 mg/d) plus chlorogenic acid (200 mg/d); group 2, caffeine (200 mg/d) plus placebo; group 3, chlorogenic acid (200 mg/d) plus placebo; group 4, placebo plus placebo. Supplementation will be daily and will supervise for 6 months.
| Status | Completed |
| Enrollment | 200 |
| Est. completion date | March 2019 |
| Est. primary completion date | September 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 30 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Patient diagnosed with type 2 diabetes based on American Diabetes Association (ADA) definition or who only take oral antidiabetic drug. - CAPscore >263 Exclusion Criteria: - Criteria: - Taking any kind of antibiotics two weeks before recruitment; - History of alcohol consumption ; - pregnancy or lactation; - Professional athletes; - Other liver disease (viral/etc); - High dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs; - A history of Cardiovascular disease; - Renal disease, Celiac disease, Cirrhosis; - History of Upper Gastrointestinal surgery ; - A history of hypothyroidism or Cushing's syndrome; - History of drug dependence; - Body mass index (BMI) =35 kg/m2; - A restrictive diet or weight change = 5 kg during the 3 months prior to study; - Any change in treatment with oral hypoglycemic; anti hypertensive and antilipid agents during the study; - Use of weight loss medications |
| Country | Name | City | State |
|---|---|---|---|
| Iran, Islamic Republic of | NNFTRI clinic | Tehran |
| Lead Sponsor | Collaborator |
|---|---|
| National Nutrition and Food Technology Institute |
Iran, Islamic Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Hepatic steatosis | measured by CAP score using Fibroscan | 6 months | |
| Secondary | Glucose | 6 months | ||
| Secondary | Glycated hemoglobin (HBA1C) | 6 months | ||
| Secondary | alanine aminotransferase (ALT) | 6 months | ||
| Secondary | aspartate aminotransferase (ALS) | 6 months | ||
| Secondary | High sensitive C reactive protein ( hs- CRP) | 6 months | ||
| Secondary | gut microbiota | 3 months |