Using electroacupuncture to help obese patients with prediabetes lose weight

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

This study is testing if electroacupuncture can help obese people with prediabetes lose weight better than a fake acupuncture treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 256 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05237089 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects and safety of electroacupuncture on weight loss in obese patients who have prediabetes. A total of 256 participants will be randomly assigned to either an electroacupuncture group, receiving treatment along with health education, or a sham acupuncture group, receiving superficial acupuncture with health education. The intervention will consist of 56 sessions over 24 weeks, followed by a 24-week follow-up period to assess weight loss and health outcomes. The study aims to provide evidence on the effectiveness of electroacupuncture compared to sham treatment in managing obesity.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-65 with a BMI of 24.0 kg/m2 or higher and prediabetes indicators.

Not a fit: Patients with diagnosed diabetes or secondary obesity due to other medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new, effective treatment option for weight loss in obese patients with prediabetes.

How similar studies have performed: While acupuncture has been used for weight loss, the specific use of electroacupuncture in this context is less established, making this study a novel approach.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Municipal Hospital of Traditional Chinese Medicine — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Shifen Xu, PhD

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