Clinical Trial Details

Trial ID: L0736
Source ID: IRCT20181119041701N1
Associated Drug: Stevia Dry Leaves
Title: the Effect of Stevia Dry Leaves on Serum Levels of Liver Enzymes, Lipid Profile, Glycemic Indicators, Adiponectin and Leptin in Overweight and Obese Diabetic Patients with Non-Alcoholic Fatty Liver
Acronym: --
Status: Not Recruiting
Study Results: No Results Available
Results: --
Conditions: Condition 1: Diabetes. Condition 2: Non-alcoholic fatty liver. <br>Type 2 diabetes mellitus without complications <br>Fatty (change of) liver, not elsewhere classified;E11.9;K76.0
Interventions: Intervention 1: Intervention group: Everyone will receive 2 capsules 250 mg stevia per day for 8 weeks. Intervention 2: Control group: Everyone will receive placebo, starch, 2 capsules 250 mg per day for 8 weeks.
Outcome Measures: Lipid profile. Timepoint: Before and after 8 weeks of intervention. Method of measurement: Laboratory test.;Liver Enzymes. Timepoint: Before and after 8 weeks of intervention. Method of measurement: Laboratory test.;Fasting blood sugar. Timepoint: Before and after 8 weeks of intervention. Method of measurement: Laboratory test.;Insulin resistance. Timepoint: Before and after 8 weeks of intervention. Method of measurement: Using the HOMA-IR formula.;Leptin. Timepoint: Before and after 8 weeks of intervention. Method of measurement: Laboratory test.;Adiponectin. Timepoint: Before and after 8 weeks of intervention. Method of measurement: Laboratory test.;Body mass index. Timepoint: Before and after 8 weeks of intervention. Method of measurement: The weight ratio in kilograms to the second power of height in meters.Systolic blood pressure. Timepoint: Before and after 8 weeks of intervention. Method of measurement: Mercury pressure gauge.;Diastolic blood pressure. Timepoint: Before and after 8 weeks of intervention. Method of measurement: Mercury pressure gauge.
Sponsor/Collaborators: Ahvaz University of Medical Sciences
Gender: All
Age: 20 years60 years
Phases: Phase 3
Enrollment: 50
Study Type: interventional
Study Designs: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization? Use random numbers Table, Blinding description: The type of blindness in our study will be doub
Start Date: 05/07/2019
Completion Date: --
Results First Posted: --
Last Update Posted: 26 August 2019
Locations: Iran (Islamic Republic of)
URL: http://en.irct.ir/trial/35455