Acupuncture to reduce weight and belly fat in people with prediabetes

Acupuncture for Prediabetes With Combined Obesity: a Multicenter Randomized Controlled Trial

This trial will try acupuncture versus a sham procedure in adults with prediabetes and combined obesity to see if it helps them lose weight, shrink their waist, and improve blood sugar and cholesterol.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 260 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06359418 on ClinicalTrials.gov

What this trial studies

This randomized, controlled trial compares true acupuncture with sham acupuncture in adults aged 18–64 who meet criteria for both general and abdominal obesity and for prediabetes. Participants receive regular acupuncture sessions and outcomes tracked include body weight, waist circumference, glucose metabolism markers, and blood lipid levels. Key exclusions include endocrine causes of obesity, established diabetes, significant liver damage, and recent use of medications known to cause weight gain. The lead site is Guang'anmen Hospital in Beijing with collaborative traditional Chinese medicine hospitals participating.

Who should consider this trial

Good fit: Adults 18–64 who meet diagnostic criteria for both general and abdominal obesity and for prediabetes, can give informed consent, and are able to attend the participating Chinese hospitals.

Not a fit: People with diabetes, obesity from endocrine disorders (like uncontrolled hypothyroidism or Cushing's), significant liver damage, or recent treatment with medications known to cause weight gain would be excluded and are unlikely to benefit from the intervention tested here.

Why it matters

Potential benefit: If successful, acupuncture could offer a low-risk, non-drug option to help people with prediabetes and obesity lose weight, reduce abdominal fat, and improve blood sugar and lipid levels.

How similar studies have performed: Previous small randomized trials and meta-analyses have reported modest weight and metabolic improvements with acupuncture, but results have been mixed and larger rigorous trials are still needed.

Eligibility criteria

Inclusion Criteria:

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Subjects are eligible to be included in the trial only if all of the following criteria apply:

1. Simultaneously meeting the diagnostic criteria for both general obesity, abdominal obesity, and prediabetes;
2. Aged 18-64 years old;
3. Informed consent obtained before any trial-related activities.

Exclusion Criteria:

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Subjects are excluded from the trial if any of the following criteria apply:

1. Obesity of known endocrine origin (e.g., untreated hypothyroidism, Cushing's syndrome, established Polycystic Ovary Syndrome);
2. impaired glucose regulation due to hyperthyroidism, endocrine tumors and extensive liver damage;
3. Diagnosis of type 1 or type 2 diabetes per the judgment of the investigator;
4. Current or history of treatment with medications that may cause significant weight gain, within 3 months prior to screening, including systemic corticosteroids (except for a short course of treatment, i.e. 7-10 days), antidepressants, antipsychotic, mood stabilizers, antiepileptic and hormone contraceptive;
5. History of pancreatitis or pancreatectomy;
6. Previous or planned (during the trial period) obesity treatment with surgery or a weight-loss device;
7. Current participation (or within the last month) in an organized weight reduction program or currently using or used medication for obesity or hyperglycemia within 3 months before screening: liraglutide, exenatide, pramlintide, orlistat, topiramate, phenteremine, or metformin (either by prescription or as part of a clinical trial);
8. A self-reported change in body weight \>5 kg within 3 months before screening irrespective of medical records;
9. Serious medical conditions (including but not limited to ongoing renal or hepatic insufficiency, congestive heart failure, myocardial infarction, stroke, hematopoietic system diseases, progressive malignant tumor or other serious consumptive diseases); history of angina pectoris, transient ischemic attack, claudication, or acute limb ischemia within the past 6 months prior to screening;
10. Serious psychiatric illness, including lifetime history of bipolar disorder, schizophrenia or other psychosis, bulimia, and anorexia nervosa; current serious personality disorder, (e.g. borderline or antisocial), current severe major depressive disorder, recent (previous 6 months) suicide attempt or current active suicidal ideation, recent hospitalization due to psychiatric illness;
11. Skin infection, blood coagulation disorders and other conditions that are not suitable for acupuncture;
12. Metal allergies or severe fear of needles;
13. Pregnant or breast-feeding women or planning to become pregnant during the study period;
14. Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol.

Where this trial is running

Beijing

• Guang'anmen Hospital, China Academy of Chinese Medical Sciences — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Zhishun Liu, PhD — Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Study coordinator: Zhishun Liu, PhD

Conditions Obesity; Abdominal Obesity; PreDiabetes; acupuncture; randomized controlled trial