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Assessement of the effects of coffee main constituents in none- alcoholic fatty liver patients with type 2 diabetes

Phase 3
Recruiting
Conditions
AFLD.
(Nonalcoholic fatty liver disease (NAFLD
Registration Number
IRCT201707024010N21
Lead Sponsor
IMAD
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
100
Inclusion Criteria

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

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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
iver fibrosis. Timepoint: Before and 24 weekes after the intervention. Method of measurement: fiberscan.;Glucose. Timepoint: Before and 24 weekes after the intervention. Method of measurement: mg/dl.;Weight. Timepoint: Before and 24 weekes after the intervention. Method of measurement: kg.;AST. Timepoint: Before and 24 weekes after the intervention. Method of measurement: U/L.;GGT. Timepoint: Before and 24 weekes after the intervention. Method of measurement: U/L.;ALT. Timepoint: Before and 24 weekes after the intervention. Method of measurement: U/L.;Liver Steatosis. Timepoint: Before and 6 weekes after the intervention. Method of measurement: ultrasonography.
Secondary Outcome Measures
NameTimeMethod
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