Effect of Electroacupuncture on Obesity

ConditionObesity

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorShanghai Municipal Hospital of Traditional Chinese Medicine

About this trial

The investigators describe a protocol for a randomized controlled trial to find out the effect and safety of electroacupuncture on losing weight in obese patients with prediabetes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female participants aged 18-65;

Participant whose BMI is ≥24.0 kg/m2;

Participants whose HbA1c measurement of 5.7-6.4% both inclusive, or fasting plasma glucose measurement ≥ 6.1 mmol/liter and <7.0 mmol/liter, or 2-hour plasma glucose measurement post-challenge (oral glucose tolerance test) ≥7.8 mmol/liter and <11.1 mmol/liter;

Participants with stable weight within 3 months before the start of the trial, fluctuated within 4 kg;

Disqualifiers

Patients with secondary obesity caused by drugs or neuro-endocrine-metabolic disorders (such as hypothalamic disease and hypopituitarism);

Patients who have been diagnosed with type I or type II diabetes;

Patients who are taking medication which cause clinically significant weight gain or loss;

Patients whose Hamilton 17-item Depression Scale (HAMD-17) score >18 or have a history of other severe psychiatric disorders;

Trial design

Design model

Parallel

Treatments tested in this trial

Electroacupuncture
Other intervention
Regular acupuncture will be applied at the main and the additional acupoints with 0.25mm\*40mm or 0.30mm\*75mm needles. The main acupoints include Shangwan (CV13), Zhongwan (CV12), Jianli (CV11), Xiawan (CV10), bilateral Quchi (LI11), Hegu (LI4), Liangmen (ST21), Tianshu (ST25), Daheng (SP15), Fujie (SP14), Shuidao (ST28), Zusanli (ST36), Fenglong (ST40), Wailing (ST26), Guilai (ST29). Additional acupoints include bilateral Shangjuxu (ST37) and Neiting (ST44), bilateral Yinlingquan (SP9) and Shuifen (CV9), Qihai (CV6) and Guanyuan (CV4). Acupuncturists will use all main acupoints and choose the combined acupoints based on the patients' patterns during each treatment session. The EA apparatus will be connected to the needles at the bilateral ST21, ST25, SP15, using continuous wave type, frequency at 3 Hz, and intensity of 4-5 mA based on the endurance of each patient. Needles will be retained for 30 minutes before removal.
Sham acupuncture
Other intervention
Patients will receive superficial acupuncture treatment at the same main acupoints as EA group with 0.22\*0.25mm needles. The electroacupuncture apparatus will connected to the needles at the bilateral Liangmen (ST21), Tianshu (ST25), Daheng (SP15) without current output. Needles will be retained for 30 minutes before removal. The treatment will be given 3 times a week in week 1-12, 2 times a week in week 13-20, and once a week in week 21-24, totaling 56 sessions of real or sham acupuncture.
Health education
Other intervention
The health management brochure will be distributed to all patients in the trial after enrollment, and health education will be arranged online or offline at week 4, 8, 12, 16, 20 and 24 for about 60 minutes, including lifestyle, diet and physical activity. According to the specific situation of each patient, healthier individual lifestyle and behavior will be recommended to all patients, but there will be no strict restrictions on the diet or physical activity.

Treatment groups

256 Participants

are divided into 2 treatment groups

Group A: EA group：Electroacupuncture+health educationActive comparator 2 interventions

Group B: Sham acupuncture group：shallow acupuncture+health educationSham comparator 2 interventions

Trial outcomes

Primary outcomes

The Percentage of patients who lost 10% of their body weight

We will calculate the proportion of people in each group who lost 10% or more of their baseline body weight at the end of the intervention period.

Time frame

week 24

Secondary outcomes

Changes of body weight from baseline to week 48

The change of body weight is an important factor of the development of diabetes. We will calculate the mean weight change in each group of patients during the intervention and follow-up period, compared with baseline data.

Time frame

baseline, week 8, week 16, week 24, week 32, week 40 and week 48

Changes of BMI from baseline to week 48

BMI is a statistical index using a person's weight and height to provide an estimate of body fat in males and females of any age. It is calculated by taking a person's weight, in kilograms, divided by their height, in meters squared, or BMI = weight (kg)/ height2 (m2). BMI is used to define a person as underweight, normal weight, overweight, or obese by the National Institute of Health (NIH).

Time frame

baseline, week 8, week 16, week 24, week 32, week 40 and week 48

Change of blood glucose from baseline to week 24

It is the concentration of glucose in the blood, including fasting plasma glucose (FBG) which reflects function of islet β cell and 2 hour postprandial blood glucose (2hPG) which reflects the reserve function of islet β cell.

Time frame

baseline, week 24

Change of HbA1c from baseline to week 24

HbA1c reflects the average blood glucose level of diabetic patients in the past 8-12 weeks. HbA1c≥5.5% indicates the presence of insulin resistance, and ≥6.5% indicates the occurrence of diabetes.

Time frame

baseline, week 24

Other outcomes

Adverse effects

Any adverse event (described as unfavourable or unintended signs, symptoms or diseases occurring during the trial) related to the intervention will be reported by patients and practitioners and accessed by the Treatment Emergent Symptom Scale (TESS) which is used as an associated indicator to mainly evaluate the safety of acupuncture treatment in this trial.

Time frame

from baseline to week 48

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Municipal Hospital of Traditional Chinese Medicine

Lead sponsor

Source ClinicalTrials.gov

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