NCT05237089

Effect of Electroacupuncture on Obesity

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Obesity has emerged as a contributing factor in diabetes mellitus. In 2015, about 4 million deaths worldwide were directly related to high BMI, accounting for 7.1% of all deaths; among them, 41% died due to cardiovascular disease, followed by diabetes mellitus. China has become the country with the largest number of obese people and diabetic patients in the world. According to the clinical practice guidelines for medical care of obese patients announced by AACE and ACE, obese patients with prediabetes can effectively prevent the development of diabetes by lose 10% or more than of their body weight. Acupuncture is a widely recognized therapy to lose weight in clinical practice. But there are some doubts about the effectiveness of acupuncture versus sham acupuncture in treating obesity due to its lack of medical evidence. This randomized placebo-controlled clinical trial is aimed to investigate the effect and safety of Electroacupuncture (EA) in obese patients with prediabetes. The investigators designed a protocol for a randomized controlled trial, in which 256 eligible patients will be randomly assigned to one of the two groups in a ratio of 1:1, the EA group (receiving EA treatment with health education) and the sham electroacupuncture (SA) group (receiving superficial acupuncture treatment with health education). A total of 56 sessions of interventions will be given for consecutive 24 weeks, followed by a 24-week follow-up period. Each session of EA or SA treatment will last for about 30 minutes. The primary outcome is the proportion of patients who lost 10% or more than of their body weight at week 24. The secondary outcomes include the change of patient's body weight and body mass index (BMI), results from the blood tests (FBG, 2hPG, HbA1c, HOMA-IR, LDL-C, HDL-C, TG and TC, ect.), the fat tissue size scanned by abdominal magnetic resonance imaging (MRI), data collected from the body composition analyzer, the and scores of the impact of weight on quality of life (IWQOL-Lite), Three Factor Eating Questionnaire - R21 (TFEQ-R21) and Food Cravings Questionnaire-Trait (FCQ-T). All adverse effects will be accessed by the Treatment Emergent Symptom Scale (TESS) from baseline to the follow-up period. The body weight and BMI will be calculated at baseline, week 8, week 16, week 24, week 32, week 40 and week 48, as well as the IWQOL-Lite, the TFEQ-R21 and the FCQ-T. Blood tests will be analyzed at baseline and week 24, as well as the body composition analyzer and the MRI scan. All patients will be provided with the same health education brochure to choose more beneficial personalized lifestyle during the 24-week intervention period. All analyses will be performed on the intention-to-treat (ITT) population of participants who have at least one treatment. Missing data will be handled using the multiple imputation method, on the assumption that values at each time point follow a specific distribution calculated by the computer software R V.3.5. The primary analysis will be a comparison of the proportion of patients who losing 10% or more than of their body weight between the two groups at 24 weeks after inclusion (comparison of the primary endpoint). Linear mixed-effects models will be used for analyses with the use of the statistical software SPSS V.20.0. The t-test will be used to compare the measurement data between either two groups from the baseline to follow-up; the rank sum test will be used for ranked data while the Chi-squared test will be used to analyze categorical data. The significance level that will be used for statistical analysis with 2-tailed testing will be 2.5%. Data values will mainly be presented as Mean±SD. The findings from this trial will help further explore the efficacy and safety of EA on losing weight for patients with obesity and prediabetes, as well as determine the differences between the EA and SA treatment.

Conditions

• Obesity

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.
OTHER	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.

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-12-31
• Completion: 2026-12-31
• First posted: 2022-02-11
• Last updated: 2022-11-10

Locations

1 site across 1 country: China