RecruitingNot ApplicableNCT05237089

Effect of Electroacupuncture on Obesity

Effects of Electroacupuncture on Weight Loss in Obese Patients With Prediabetes: a Randomized Controlled Trial

Sponsor

Shanghai Municipal Hospital of Traditional Chinese Medicine

Enrollment

256 participants

Start Date

Sep 1, 2022

Study Type

INTERVENTIONAL

Conditions

Obesity

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

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;
Participants who voluntarily agree with the investigation and sign a written informed consent form for the clinical trial.

Exclusion Criteria8

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;
Patients with severe ulcer, abscess and skin infection at the local acupuncture area;
Patients with severe diseases of multiple organs, such as heart, brain, lungs, liver, kidneys, hematopoietic system or other serious diseases;
Participants who have joined in other clinical trials or studies within the past 1 month;
Pregnant or lactating women.

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Interventions

OTHERElectroacupuncture

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.

OTHERSham 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.

OTHERHealth 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.