NCT06359418

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for not_applicable obesity

Timeline
24mo left

Started Mar 2025

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Mar 2025Apr 2028

First Submitted

Initial submission to the registry

March 24, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
11 months until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

2.3 years

First QC Date

March 24, 2024

Last Update Submit

August 16, 2025

Conditions

ObesityAbdominal ObesityPreDiabetes

Keywords

acupuncturerandomized controlled trialObesityAbdominal ObesityPreDiabetes

Outcome Measures

Primary Outcomes (2)

  • The percentage change in body weight from baseline to week 12

    The weight is measured by electronic scale with an accuracy of 0.1kg.

    week 12

  • The percentage change in waist circumference from baseline to week 12

    The waist circumference is measured by a fiberglass tape measure with an accuracy of 0.1 centimeters.

    week 12

Secondary Outcomes (28)

  • The percentage change in body weight compared to the baseline

    week 4, week 8, week 16, week 20, week 24, week 28, week 32, week 36, week 52

  • The percentage change in waist circumference compared to the baseline

    week 4, week 8, week 16, week 20, week 24, week 28, week 32, week 36, week 52

  • Achievement of a reduction in body weight of 5% or more compared to the baseline

    week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 32, week 36, week 52

  • Achievement of a reduction in body weight of 7% or more compared to the baseline

    week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 32, week 36, week 52

  • The change in body weight from baseline

    week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 32, week 36, week 52

  • +23 more secondary outcomes

Other Outcomes (6)

  • Expectance assessment

    baseline

  • Assessment of belief in acupuncture

    baseline

  • Blinding assessment

    week 12

  • +3 more other outcomes

Study Arms (2)

Acupuncture

EXPERIMENTAL

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).

Device: Acupuncture

Sham acupuncture

SHAM COMPARATOR

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).

Device: Sham acupuncture

Interventions

AcupunctureDEVICE

The acupuncture needle (size 0.30x40mm) will be inserted into DU20, EX-HN3 and GB8 acupoints at the depth of 15-30mm; The acupuncture needle (size 0.30x50mm or size 0.30x75mm) will be inserted into other acupoints at the depth of 40-70mm; Manipulation will be done after insertion (6 times of small amplitude and uniform twist).

Acupuncture
Sham acupunctureDEVICE

The acupuncture needle (size 0.20x25mm) will be inserted into all acupoints at the depth of 2mm without any manipulation.

Sham acupuncture

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects are eligible to be included in the trial only if all of the following criteria apply:
  • Simultaneously meeting the diagnostic criteria for both general obesity, abdominal obesity, and prediabetes;
  • Aged 18-64 years old;
  • Informed consent obtained before any trial-related activities.

You may not qualify if:

  • Subjects are excluded from the trial if any of the following criteria apply:
  • Obesity of known endocrine origin (e.g., untreated hypothyroidism, Cushing's syndrome, established Polycystic Ovary Syndrome);
  • impaired glucose regulation due to hyperthyroidism, endocrine tumors and extensive liver damage;
  • Diagnosis of type 1 or type 2 diabetes per the judgment of the investigator;
  • 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;
  • History of pancreatitis or pancreatectomy;
  • Previous or planned (during the trial period) obesity treatment with surgery or a weight-loss device;
  • 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);
  • A self-reported change in body weight \>5 kg within 3 months before screening irrespective of medical records;
  • 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;
  • 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;
  • Skin infection, blood coagulation disorders and other conditions that are not suitable for acupuncture;
  • Metal allergies or severe fear of needles;
  • Pregnant or breast-feeding women or planning to become pregnant during the study period;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

ObesityObesity, AbdominalPrediabetic State

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Zhishun Liu, PhD

    Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhishun Liu, PhD

CONTACT

86-010-88002331zhishunjournal@163.com

Yan Yan

CONTACT

+8618579122011yanyanxuexi@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 24, 2024

First Posted

April 11, 2024

Study Start

March 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

April 1, 2028

Last Updated

August 22, 2025

Record last verified: 2025-08

Locations

CN(1)