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IRCT20180914041035N1 IRCT 2018-10-11 Tehran University of Medical Sciences Effect of Acupuncture in Treatment of Diabetes Evaluating Therapeutic Effects of Acupuncture on Blood Glucose Level among Patients with Type 2 Diabetes Mellitus 2018-08-29 anticipated 80 Complete https://irct.ir/trial/34382 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned following simple randomization procedures to either acupuncture group (treatment group) or sham acupuncture group (control group) by means of a random number table prepared by an independent member. The allocation sequence will be concealed from the researchers in sequentially numbered, sealed, opaque envelopes. After the researcher has assessed eligibility, obtained the patient’s consent, and completed all baseline assessments of the enrolled participants, corresponding envelopes will be opened, and the treatment allocation will be revealed, Blinding description: All participants will be blinded to the treatment assignments. The primary investigator will be blinded to patients’ information and the results from the measurements, however blinding the primary researcher from participants’ allocation is not possible. The data will be analysed by an independent outcome assessor who will be kept blinded to the participants’ allocation. N/A Type 2 Diabetes Mellitus. Intervention 1: Intervention group: Acupuncture. According to textbooks, literature review and the clinical experience of the principal researcher, fifteen body acupoints were selected including Waiguan (TE 5), Tianshu (ST 25), Zusanli (ST 36), Fenglong (ST 40), Qihai (CV 6), Zhongwan (CV 12), Feishu (BL 13), Pishu (BL 20), Shenshu (BL 23), Xuehai (SP 10), Sanyinjiao (SP 6), Taichong (LR 3), Hegu (LI 4), Quchi (LI 11) and Taixi (KI 3). Sterile stainless steel acupuncture needles (0.25mm × 40mm, Zhongyan Taihe medical instrument, Beijing, China) will be inserted perpendicularly at a depth of 10-15 mm into the acupoints, and after the needle sensation (Deqi) is arrived, they are retained for 20 minutes. The treatment will be performed for 12 sessions in 6 weeks (three times per week for two weeks, then two times per week for two weeks, and then once weekly for two weeks), and maintenance treatment will be performed for two sessions once every other week (Totally, 14 sessions of treatment during 10 weeks). Intervention 2: Control group: Sham acupuncture. Very small needles (0.16mm × 7mm) will be inserted very shallow (3-5mm) without a Deqi sensation at the non-acupoints matched to the actual acupunctre points and they are retained for 20 minutes. The treatment will be performed for 12 sessions in 6 weeks (three times per week for two weeks, then two times per week for two weeks, and then once weekly for two weeks), and maintenance treatment will be performed for two sessions once every other week (Totally, 14 sessions of treatment during 10 weeks). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Amir Hooman Kazemi
No. 27, North Sarparast St, West Taleghani St, Felestin Square
Tehran Iran (Islamic Republic of) ۱۴۱۷۶۱۴۴۱۸ +98 21 2298 8548 hooman_k@tums.ac.ir Tehran University of Medical Sciences scientific Amir Hooman Kazemi
No. 27, North Sarparast St, West Taleghani St, Felestin Square
Tehran Iran (Islamic Republic of) ۱۴۱۷۶۱۴۴۱۸ +98 21 2298 8548 hooman_k@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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 35 years 65 years Both 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) E11 Type 2 diabetes mellitus Treatment - Devices Treatment - Devices Intervention group: Acupuncture. According to textbooks, literature review and the clinical experience of the principal researcher, fifteen body acupoints were selected including Waiguan (TE 5), Tianshu (ST 25), Zusanli (ST 36), Fenglong (ST 40), Qihai (CV 6), Zhongwan (CV 12), Feishu (BL 13), Pishu (BL 20), Shenshu (BL 23), Xuehai (SP 10), Sanyinjiao (SP 6), Taichong (LR 3), Hegu (LI 4), Quchi (LI 11) and Taixi (KI 3). Sterile stainless steel acupuncture needles (0.25mm × 40mm, Zhongyan Taihe medical instrument, Beijing, China) will be inserted perpendicularly at a depth of 10-15 mm into the acupoints, and after the needle sensation (Deqi) is arrived, they are retained for 20 minutes. The treatment will be performed for 12 sessions in 6 weeks (three times per week for two weeks, then two times per week for two weeks, and then once weekly for two weeks), and maintenance treatment will be performed for two sessions once every other week (Totally, 14 sessions of treatment during 10 weeks). Control group: Sham acupuncture. Very small needles (0.16mm × 7mm) will be inserted very shallow (3-5mm) without a Deqi sensation at the non-acupoints matched to the actual acupunctre points and they are retained for 20 minutes. The treatment will be performed for 12 sessions in 6 weeks (three times per week for two weeks, then two times per week for two weeks, and then once weekly for two weeks), and maintenance treatment will be performed for two sessions once every other week (Totally, 14 sessions of treatment during 10 weeks). 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. Hemoglobin A1c. Timepoint: Evaluating HbA1c at baseline (before the treatment) and 12 weeks after the initiation of treatment. Method of measurement: Laboratory kit. Tehran University of Medical Sciences Approved 2018-08-28 Ethics committee of Tehran University of Medical Sciences 6th floor, central building, Qods street, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)