Effect of Electroacupuncture on Obesity

NCT05237089 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Municipal Hospital of Traditional Chinese Medicine

Phase

Not applicable

Started

2022-09-01

Last updated

2022-11-10

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

ElectroacupunctureSham acupunctureHealth education

Electroacupuncture: 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: 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: 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.

Study summary

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

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: 1. Male or female participants aged 18-65; 2. Participant whose BMI is ≥24.0 kg/m2; 3. 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; 4. Participants with stable weight within 3 months before the start of the trial, fluctuated within 4 kg; 5. Participants who voluntarily agree with the investigation and sign a written informed consent form for the clinical trial. Exclusion Criteria: 1. Patients with secondary obesity caused by drugs or neuro-endocrine-metabolic disorders (such as hypothalamic disease and hypopituitarism); 2. Patients who have been diagnosed with type I or type II diabetes; 3. Patients who are taking medication which cause clinically significant weight gain or loss; 4. Patients whose Hamilton 17-item Depression Scale (HAMD-17) score \>18 or have a history of other severe psychiatric disorders; 5. Patients with severe ulcer, abscess and skin infection at the local acupuncture area; 6. Patients with severe diseases of multiple organs, such as heart, brain, lungs, liver, kidneys, hematopoietic system or other serious diseases; 7. Participants who have joined in other clinical trials or studies within the past 1 month; 8. Pregnant or lactating women.

Primary outcome measure(s)

The Percentage of patients who lost 10% of their body weight — week 24
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.

Trial sites (1)

Facility	City	Region	Status
Shanghai Municipal Hospital of Traditional Chinese Medicine	Shanghai	Shanghai Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05237089 on ClinicalTrials.gov ↗ ← All trials in China