Diabetes Mellitus, Type 2, Fatty Liver
Conditions
Keywords
Ginger, Medicine, traditional, Herbal medicine
Brief summary
The investigators want to evaluate the effects and safety of ginger in treatment of nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM).
Detailed description
Ginger (Zingiber officinale Roscoe) has been cultivated for medicinal and culinary purposes for at least two millennia. It contains several hundred valuable compounds and new constituents are still being found. Ginger's high antioxidant value has proved highly effective with its ability to scavenge a number of free radicals and protect cell membrane lipids from oxidation in a dose-dependent manner. In a randomized double-blind placebo-controlled clinical trial, the investigators want to investigate the effects of ginger in treatment of nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM).
Interventions
DRUGGinger
Ginger powder capsule 1000 mg twice daily for 3 months
DRUGPlacebo
Placebo powder 2 capsules twice daily for 3 months
Sponsors
Shiraz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Controlled type 2 diabetes mellitus (HbA1c\<7%) * Age: 20-65 years * Body mass index: 18-35 kg/m2 * Serum ALT level: \>60 U/Lit. in males, \>38 U/Lit. in females * Grade \>=2 fatty liver in liver sonography
Exclusion criteria
* Pregnancy * Acute or chronic liver failure * Acute or chronic renal failure * Autoimmune or viral hepatitis * Wilson's disease * Alcoholism * Malignancy * Hypothyroidism or hyperthyroidism * Drug used in last three months: OCP, vitamin E, ursodeoxycholic acid, glucocorticoids.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ALT (liver transaminases) level | Baseline and 3 months | Change in the concentration of ALT (liver transaminases) |
| Change in score of fatty liver in fibroscan | Baseline and 3 months | Change in score of fatty liver in fibroscan (elastography) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in AST (liver transaminases) level | Baseline and 3 months | Change in the concentration of AST (liver transaminases) |
| Change in Gama GT (γ-glutamyl transpeptidase) levels | Baseline and 3 months | Change in the concentration of Gama GT (γ-glutamyl transpeptidase) |
| Number of patients with adverse events | 4 months | Number of patients with adverse events |
Countries
Iran
Outcome results
None listed