Effect of Electroacupuncture on Obesity

NCT05237089 | Recruiting DMC

• 1 other identifier: XSF20211230
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

Electroacupuncture; Obesity; Prediabetes; Sham acupuncture; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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.

  week 24

Secondary Outcomes (13)

• Changes of body weight from baseline to week 48

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

• Changes of BMI from baseline to week 48

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

• Change of blood glucose from baseline to week 24

  baseline, week 24

• Change of HbA1c from baseline to week 24

  baseline, week 24

• Change of insulin resistance index (HOMA-IR) from baseline to week 24

  baseline, week 24

Other Outcomes (1)

• Adverse effects

  from baseline to week 48

Study Arms (2)

EA group：Electroacupuncture+health education

ACTIVE COMPARATOR

Acupuncture is the most popular adjuvant and alternative therapy in China, and it has been used to treat various diseases for thousands of years. Electroacupuncture is an innovation of traditional Chinese acupuncture, which improves the clinical effect by transmitting electrical pulses to the needles and then enhances the stimulation at the acupoints to receive better effects. Studies show that EA has been used as an alternative therapy for obesity in clinical practice.

Other: Electroacupuncture; Other: Health education

Sham acupuncture group：shallow acupuncture+health education

SHAM COMPARATOR

Sham acupuncture method in this study is set as the superficial acupuncture manipulated at the same main acupoints with the thinner and shorter needles. The aim of the sham acupuncture is to eliminate the possible placebo effect of EA treatment.

Other: Sham acupuncture; Other: Health education

Interventions

Electroacupuncture OTHER

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.

EA group：Electroacupuncture+health education

Sham acupuncture OTHER

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.

Sham acupuncture group：shallow acupuncture+health education

Health education OTHER

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.

EA group：Electroacupuncture+health education; Sham acupuncture group：shallow acupuncture+health education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Municipal Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Shanghai Municipal Hospital of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200071, China

RECRUITING

Related Publications (1)

• Li X, Lin J, Hu C, Liu B, Li F, Li J, Zeng X, Li S, Mi Y, Yin X, Xu S. Effect and safety of electroacupuncture on weight loss in obese patients with pre-diabetes: study protocol of a randomised controlled trial. BMJ Open. 2024 Mar 8;14(3):e075873. doi: 10.1136/bmjopen-2023-075873.

  PMID: 38458786 DERIVED

MeSH Terms

Conditions

Obesity; Prediabetic State

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Shifen Xu, PhD

  Shanghai Municipal Hospital of Traditional Chinese Medicine

  STUDY DIRECTOR

Central Study Contacts

Shifen Xu, PhD

CONTACT

+8613761931393; xu_teacher2006@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the acupuncturists in this study will know about the group assignment of patients. All other relevant parties will be blinded to the intervention. Participants will be informed that they will be randomly allocated to the electroacupuncture group or the superficial acupuncture group before study participation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All eligible participants will be randomly assigned into two group at a ratio of 1:1, the Electroacupuncture group and the Sham acupuncture group (the control group).

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: February 11, 2022
• Study Start: September 1, 2022
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: All data and the protocol will be available after publication in peer-reviewed international journals for 3 years.
• Access Criteria: The data in this trial will be publicly available from the corresponding author upon reasonable request.

Locations

CN (1)