Effect of Acupuncture in Treatment of Diabetes
- Conditions
- Type 2 Diabetes Mellitus.Type 2 diabetes mellitus
- Registration Number
- IRCT20180914041035N1
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
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
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)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Hemoglobin A1c. Timepoint: Evaluating HbA1c at baseline (before the treatment) and 12 weeks after the initiation of treatment. Method of measurement: Laboratory kit.