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Evaluating Therapeutic Effects of Acupuncture on Blood Glucose Level among Patients with Type 2 Diabetes Mellitus

Protocol summary

Study aim
The aim of this study is to compare the therapeutic effects of acupuncture with sham acupuncture on fasting blood glucose level and hemoglobin A1c among patients with type 2 diabetes mellitus under treatment with metformin.
Design
Parallel, double blind, sham-controlled randomized clinical trial
Settings and conduct
The study will be conducted on 80 patients with diagnosis of type 2 diabetes mellitus referred to Traditional Medicine clinic affiliated to School of Traditional Persian Medicine, Tehran University of Medical Sciences, that will be randomized to acupuncture (n=40) and sham acupuncture (n=40) groups.
Participants/Inclusion and exclusion criteria
Eligible participants are patients aged between 35 and 65 years with diagnosis of type 2 diabetes mellitus, who are under treatment with metformin to control their blood glucose (500-1500 mg/day), with fasting plasma glucose < 250 mg/dl or HbA1c < 9
Intervention groups
In addition to metformin therapy, patients in the acupuncture group will receive needling at 15 acupoints for 20 min. Control group will be treated with very small needles inserted very shallow (3-5 mm) without a Deqi sensation at the non-acupoints. Both groups will be treated 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).
Main outcome variables
Fasting plasma glucose (FPG) will be measured before treatment, and after one, two, four, six and twelve weeks of treatment. HbA1c will be assessed once before treatment and once twelve weeks after the initiation of treatment.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180914041035N1
Registration date: 2018-10-11, 1397/07/19
Registration timing: registered_while_recruiting

Last update: 2018-10-11, 1397/07/19
Update count: 0
Registration date
2018-10-11, 1397/07/19
Registrant information
Name
Amir Hooman Kazemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2298 8548
Email address
hooman_k@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-29, 1397/06/07
Expected recruitment end date
2019-02-26, 1397/12/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating Therapeutic Effects of Acupuncture on Blood Glucose Level among Patients with Type 2 Diabetes Mellitus
Public title
Effect of Acupuncture in Treatment of Diabetes
Purpose
Treatment
Inclusion/Exclusion 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:
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)
Age
From 35 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
6th floor, central building, Qods street, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۸
Approval date
2018-08-28, 1397/06/06
Ethics committee reference number
IR.TUMS.VCR.REC.1397.369

Health conditions studied

1

Description of health condition studied
Type 2 Diabetes Mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
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 outcomes

1

Description
Hemoglobin A1c
Timepoint
Evaluating HbA1c at baseline (before the treatment) and 12 weeks after the initiation of treatment
Method of measurement
Laboratory kit

Intervention groups

1

Description
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).
Category
Treatment - Devices

2

Description
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).
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Traditional Medicine Clinic of Traditional Persian medicine School of Tehran University of Medical S
Full name of responsible person
Amir Hooman Kazemi
Street address
No. 27, North Sarparast Street, West Taleqani Ave
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۸
Phone
+98 21 2298 8548
Email
info-tim@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
6th floor, central building, Qods street, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۸
Phone
+98 21 8163 3698
Email
research@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Hooman Kazemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No. 27, North Sarparast St, West Taleghani St, Felestin Square
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۸
Phone
+98 21 2298 8548
Fax
Email
hooman_k@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Hooman Kazemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No. 27, North Sarparast St, West Taleghani St, Felestin Square
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۸
Phone
+98 21 2298 8548
Fax
Email
hooman_k@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Hooman Kazemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No. 27, North Sarparast St, West Taleghani St, Felestin Square
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۸
Phone
+98 21 2298 8548
Fax
Email
hooman_k@tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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