Acupuncture for Prediabetes With Combined Obesity

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Enrolling

Conditions: Abdominal Obesity; Obesity; PreDiabetes

Treatments: Device: Acupuncture; Device: Sham acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06359418

2024-007-KY

Details and patient eligibility

About

The clinical trial aims to evaluate the efficacy and safety of acupuncture in reducing weight and waist circumference while modulating glucose and lipid metabolism in Prediabetes with Combined Obesity.

Enrollment: 260 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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260 participants in 2 patient groups

Acupuncture

Experimental group

Description:

The participants in the acupuncture group will receive treatment that consists of 28 acupuncture sessions over a 12-week (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 8 weeks) period after baseline, each for 30 minutes. Hwato brand disposable acupuncture needles (size 0.30 x75mm; size 0.30 x 50mm; size 0.30 x 40mm) will be used. BaiHui(DU20), YinTang(EX-HN3), ShuaiGu(GB8), QuChi ( LI11), ZhongWan(RN12), XiaWan(RN10), TianShu(ST25), GuanYuan(RN4), FengLong(ST40), Daimai(GB26) and Fujie(SP14) were selected as acupoints protocol. At the same time, all participants will receive standardized lifestyle intervention counseling from randomization to end of whole study period, about once a month. Participants were advised to achieve a reduced-calorie diet (500-kcal deficit per day relative to the energy expenditure estimated at the time they underwent randomization) and increased physical activity (with 150 minutes per week of physical activity).

Treatment:

Device: Acupuncture

Sham acupuncture

Sham Comparator group

Description:

The participants in the sham acupuncture group will receive shallow needling at sham DU20, EX-HN3, GB8, LI11, RN12, RN10, ST25, RN4, ST40, GB26 and SP14. The protocol includes the same duration and frequency of sessions as for the acupuncture treatment, but the treatment was delivered superficially at non-acupuncture points 10-20 mm to the lateral of corresponding acupuncture and not above a meridian line. The Hwato brand disposable acupuncture needles(size 0.20 x25mm) will be inserted. At the same time, all participants will receive standardized lifestyle intervention counseling from randomization to end of whole study period, about once a month. Participants were advised to achieve a reduced-calorie diet (500-kcal deficit per day relative to the energy expenditure estimated at the time they underwent randomization) and increased physical activity (with 150 minutes per week of physical activity).

Treatment:

Device: Sham acupuncture