type II Diabetes. Type 2 diabetes mellitus
Conditions
Interventions
Intervention 1: The participants receiving placebo at a dose of 10 mg per day for three months (in the morning and with water) or placebo, in combination with the patient's previous medications, inclu
Sponsors
Bojnourd University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Type 2 diabetic patients who have been diagnosed for at least 6 months and treated at least with two anti-diabetic drugs. 710 BMI= Kg/m245
Exclusion criteria
Exclusion criteria: EGFR<45 Liver Failure Type1 diabetes History of ketosis History of frequent falls and recurrent infections Significant renal disease requiring dialysis Inappropriate drug use Serious medical conditions such as severe cardiovascular disease such as heart attack or stroke in the last three months Blood pressure above 180/110 mmHg Major surgery performed in the last 28 days Cancer treatment in the past 5 years Receiving systemic glucocorticoids Alcohol or substance abuse Pregnancy and lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of glycated hemoglobin or long-term blood sugar. Timepoint: Weeks 0 and 24. Method of measurement: Using the laboratory kit.;Fasting blood sugar measurement. Timepoint: Weeks 0 and 24. Method of measurement: Using the laboratory kit.;Measurement of glomerular filtration level for indirect evaluation of kidney status. Timepoint: weeks 0 and 24. Method of measurement: Using the laboratory kit.;Measurement of urine albumin concentration. Timepoint: weeks 0 and 24. Method of measurement: Using the laboratory kit.;Urine creatinine measurement. Timepoint: weeks 0 and 24. Method of measurement: Using the laboratory kit.;Measurement of changes in urinary albumin / creatinine ratio. Timepoint: weeks 0 and 24. Method of measurement: Using the laboratory kit.;Evaluation of aspartate aminotransferase level for evaluation of liver function. Timepoint: weeks 0 and 24. Method of measurement: Using the laboratory kit.;Evaluation of alanine aminotransferase level for evaluation of liver function. Timepoint: weeks 0 and 24. Method of measurement: Using the laboratory kit.;Measurement of blood alkaline phosphatase level for evaluation of hepatic function. Timepoint: weeks 0 and 24. Method of measurement: Using the laboratory kit.;Patient quality of life. Timepoint: Weeks 0 and 24. Method of measurement: DQOL questionnaire.;Retinopathy studies. Timepoint: Weeks 0 and 24. Method of measurement: Measurement of central macular thickness, corrected visual acuity, thickness of retinal and central subcutaneous tissue.;Neuropathy examinations. Timepoint: Weeks 0 and 24. Method of measurement: Pain score changes, EMG and NCV. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHabibeh Sadat Shakeri
Bojnourd University of Medical Sciences
Outcome results
None listed