AzTrials
AzTrials

ObesityNCT06359418

Acupuncture for Prediabetes With Combined Obesity

A study testing Acupuncture in people with Obesity and Abdominal Obesity, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Obesity, Abdominal Obesity, PreDiabetes
What is being tested?
Acupuncture
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
260 participants
Where
1 siteChina
Study dates
1 Mar 2025to 1 Apr 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • -
  • 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.

Who cannot join

  • -
  • 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;
Show all 16Show fewer
  • 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;
  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Guang'anmen Hospital, China Academy of Chinese Medical Sciences

    Beijing

    Zhishun Liu, PhD, +861088002331, zhishunjournal@163.com

    Recruiting

Other trials in China

About this study

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

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.

Being tested
Acupuncture, Sham acupuncture
Keywords
acupuncture, randomized controlled trial, Obesity, Abdominal Obesity, PreDiabetes
Medical subject headings
Obesity, Obesity, Abdominal, Prediabetic State

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

  • Sham acupunctureDevice

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

Study groups in NCT06359418
Study groupRoleWhat they receive
AcupunctureExperimentalThe 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).
Receives: Device: Acupuncture
Sham acupunctureSham comparatorThe 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).
Receives: Device: Sham acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The percentage change in body weight from baseline to week 12

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

    Measured: week 12

  2. 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.

    Measured: week 12

Secondary outcomes (28)
  1. The percentage change in body weight compared to the baseline

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

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

  2. The percentage change in waist circumference compared to the baseline

    Waist circumference measurements are accurate to 0.1cm.

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

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

    A 5% reduction is the weight loss target for obese patients recommended in most guidelines.

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

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

    A 7% reduction is a weight loss target for obese patients with other metabolic diseases recommended in most guidelines.

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

  5. The change in body weight from baseline

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

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

  6. The change in waist circumference from baseline

    Waist circumference measurements are accurate to 0.1cm.

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

  7. The proportion of participants reverting to normoglycaemia

    The determination is based on the results of blood glucose laboratory parameters.

    Measured: week 12, week 36, week 52

  8. The proportion of participants developing diabetes

    The determination is based on the results of blood glucose laboratory parameters.

    Measured: week 12, week 36, week 52

  9. The change in 2hPG from baseline and percentage of patients who returned to normal

    2hPG, 2-hour post-load Plasma Glucose, will be measured by oral glucose tolerance test, in mmol/L.

    Measured: week 12, week 36, week 52

  10. The change in FPG from baseline and percentage of patients who returned to normal

    FPG is fasting plasma glucose, the result will be reported in mmol/L.

    Measured: week 12, week 36, week 52

  11. The change in HbA1c from baseline and percentage of patients who returned to normal

    HbA1c is glycated haemoglobin, the result will be reported in percentage (%) units.

    Measured: week 12, week 36, week 52

  12. The change in 1hPG from baseline and percentage of patients who returned to normal

    1hPG, 1-hour post-load Plasma Glucose, will be measured by oral glucose tolerance test, in mmol/L.

    Measured: week 12, week 36, week 52

  13. Changes in appetite VAS score from baseline

    VAS=visual analogue scale; The VAS of appetite is a 100mm with two ends pointing to "none" and "difficult to control", respectively, and the subjects mark them on the online segment according to their perception. Appetite is quantitatively evaluated by measuring the distance from the left side of the segment to the marked point.

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

  14. The change in BMI from baseline

    BMI=Body Mass Index, weight and height will be combined to report BMI in kg/m^2.

    Measured: week 4, week 8, week 12, week 16, week 24, week 36, week 52

  15. The change in WHR from baseline

    WHR=Waist-to-Hip Ratio, the ratio of waist to hip circumference, waist and hip circumference are accurate to 0.1cm.

    Measured: week 4, week 8, week 12, week 16, week 24, week 36, week 52

  16. The change in WHtR from baseline

    WHtR=waist-to-Height Ratio, the ratio of waist circumference to height. Both are in cm units, accurate to 0.1cm.

    Measured: week 4, week 8, week 12, week 16, week 24, week 36, week 52

  17. The change in FINS from baseline

    FINS is fasting insulin, the result will be reported in pmol/L.

    Measured: week 12, week 36, week 52

  18. The change in HOMA-IR from baseline

    HOMA, Homeostatic Model Assessment, is a mathematical model reflecting the interaction of glucose and insulin in different organs (including pancreas, liver, and surrounding tissues). lt was first proposed by Matthews in 1985. Insulin Resistance (HOMA-IR) will be evaluated by fasting plasma glucose (FPG) and fasting insulin (FlNS). The calculation method is HOMA-IR=FPG xFINS/22.5.

    Measured: week 12, week 36, week 52

  19. The change in HOMA-β from baseline

    HOMA, Homeostatic Model Assessment, is a mathematical model reflecting the interaction of glucose and insulin in different organs (including pancreas, liver, and surrounding tissues). lt was first proposed by Matthews in 1985. Islet β cell function (HOMA-β ) will be evaluated by fasting plasma glucose (FPG) and fasting insulin (FlNS). The calculation method is HOMA- β = 20 x FINS/ (FPG-3.5).

    Measured: week 12, week 36, week 52

  20. The change in Serum total cholesterol from baseline

    The Serum total cholesterol will be reported in mmol/L.

    Measured: week 12, week 36, week 52

  21. The change in Triglyceride from baseline

    The Triglyceride will be reported in mmol/L.

    Measured: week 12, week 36, week 52

  22. The change in Low-Density Lipoprotein Cholesterol from baseline

    The Low-Density Lipoprotein Cholesterol will be reported in mmol/L.

    Measured: week 12, week 36, week 52

  23. The change in High-Density Lipoprotein Cholesterol from baseline

    The High-Density Lipoprotein Cholesterol will be reported in mmol/L.

    Measured: week 12, week 36, week 52

  24. The change in Serum Uric Acid from baseline

    The Serum Uric Acid will be reported in μmol/L.

    Measured: week 12, week 36, week 52

  25. The change in C-reactive protein from baseline

    The C-reactive protein will be reported in mg/L.

    Measured: week 12, week 36, week 52

  26. The change in blood pressure from baseline

    Record the values of systolic blood pressure and diastolic blood pressure in mmHg.

    Measured: week 4, week 8, week 12, week 16, week 24, week 36, week 52

  27. Changes of the score of the European five-dimensional Health scale (EQ-5D-5L) compared with the baseline.

    EQ-5D-5L=European Quality of Life Five Dimension Five Level Scale Questionnaire. The questionnaire which is widely used to evaluate the quality of life of the general population is divided into two parts: EQ-5D health description system and EQ-VAS. The score was calculated by calculating formula according to the choices made by the subjects in the questionnaire.

    Measured: week 12, week 36

  28. Changes of the PHQ-4 score from the baseline.

    PHQ-4=patient health questionnaire-4. PHQ-4 consists of the first two items in PHQ-9 (PHQ-2) and the first two items in GAD-7 (GAD-2), including depression and anxiety. It is translated into Chinese by scholars and verified by scholars. It has good reliability and validity and is suitable for depression and anxiety screening.

    Measured: week 12, week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2024
  2. Study start1 Mar 2025
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06359418
Sponsor's protocol ID
2024-007-KY
Status last verified
Aug 2025
First submitted
24 Mar 2024
Last updated
22 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture in people with Obesity and Abdominal Obesity, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhishun Liu, PhD (86-010-88002331, zhishunjournal@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The percentage change in body weight from baseline to week 12 (time frame: week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in