Type 2 Diabetes Mellitus. Type 2 diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with diagnosis of type 2 diabetes mellitus according to American diabetes association diagnostic criteria, who are under treatment with metformin to control their blood glucose (500-1500 mg/day) Signed the written informed consent Fasting plasma glucose between 140-250 mg/dL Aged 35-65 years
Exclusion criteria
Exclusion criteria: Cardiovascular diseases (history of heart failure, New York heart association function class III-IV, myocardial infarction, acute coronary syndromes, pacemaker implantation, coronary revascularization and stroke) Renal impairment (urinary albumin excretion = 30 mg/day, estimated glomerular filtration rate < 60 mL/min/1.73 m2) Hepatic impairment (abnormal serum aminotransferases, liver cirrhosis) Cognitive impairment, inability of cooperation Fasting plasma glucose = 250 mg/dL or hemoglobin A1C = 9 Pregnancy or breastfeeding Diabetic patients that use other medications than metformin to control their blood glucose such as insulin Evidence of lower limb infection, wound and ischemia (ecchymosis, bright skin, ABI<0.9)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting plasma glucose. Timepoint: Evaluating Fasting plasma glucose at baseline (before the treatment), and 1, 2, 4, 6 and 12 weeks after the initiation of treatment. Method of measurement: Laboratory kit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemoglobin A1c. Timepoint: Evaluating HbA1c at baseline (before the treatment) and 12 weeks after the initiation of treatment. Method of measurement: Laboratory kit. | — |
Countries
Iran (Islamic Republic of)
Contacts
Tehran University of Medical Sciences