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NCT Number: NCT06359418

Acupuncture for Prediabetes With Combined Obesity

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.

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Key information

Conditions

Obesity Abdominal Obesity Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms PreDiabetes Prediabetic State Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, China

Location status: Recruiting

Location contact

Zhishun Liu, PhD

CONTACT

[email protected]

+861088002331

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

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.

Exclusion criteria

-

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;
  • 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.

Treatment and study plan

acupuncture

Device

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 acupuncture

Device

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

Primary outcomes

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

    Time frame: week 12

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

  2. The percentage change in waist circumference from baseline to week 12

    Time frame: week 12

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

Secondary outcomes

  1. The percentage change in body weight compared to the baseline

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

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

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

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

    Waist circumference measurements are accurate to 0.1cm.

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

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

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

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

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

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

  5. The change in body weight from baseline

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

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

  6. The change in waist circumference from baseline

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

    Waist circumference measurements are accurate to 0.1cm.

  7. The proportion of participants reverting to normoglycaemia

    Time frame: week 12, week 36, week 52

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

  8. The proportion of participants developing diabetes

    Time frame: week 12, week 36, week 52

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

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

    Time frame: week 12, week 36, week 52

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

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

    Time frame: week 12, week 36, week 52

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

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

    Time frame: week 12, week 36, week 52

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

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

    Time frame: week 12, week 36, week 52

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

  13. Changes in appetite VAS score from baseline

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

    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.

  14. The change in BMI from baseline

    Time frame: week 4, week 8, week 12, week 16, week 24, week 36, week 52

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

  15. The change in WHR from baseline

    Time frame: week 4, week 8, week 12, week 16, week 24, week 36, week 52

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

  16. The change in WHtR from baseline

    Time frame: week 4, week 8, week 12, week 16, week 24, week 36, week 52

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

  17. The change in FINS from baseline

    Time frame: week 12, week 36, week 52

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

  18. The change in HOMA-IR from baseline

    Time frame: week 12, week 36, week 52

    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.

  19. The change in HOMA-β from baseline

    Time frame: week 12, week 36, week 52

    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).

  20. The change in Serum total cholesterol from baseline

    Time frame: week 12, week 36, week 52

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

  21. The change in Triglyceride from baseline

    Time frame: week 12, week 36, week 52

    The Triglyceride will be reported in mmol/L.

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

    Time frame: week 12, week 36, week 52

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

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

    Time frame: week 12, week 36, week 52

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

  24. The change in Serum Uric Acid from baseline

    Time frame: week 12, week 36, week 52

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

  25. The change in C-reactive protein from baseline

    Time frame: week 12, week 36, week 52

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

  26. The change in blood pressure from baseline

    Time frame: week 4, week 8, week 12, week 16, week 24, week 36, week 52

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

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

    Time frame: week 12, week 36

    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.

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

    Time frame: week 12, week 36

    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.

Other outcomes

  1. Expectance assessment

    Time frame: baseline

    Participants will be asked the following question: What do you think will happen to your obesity and prediabetes in 3 months?

  2. Assessment of belief in acupuncture

    Time frame: baseline

    Participants will be asked to answer "do you think acupuncture is helpful for obesity and prediabetes?" And three other related questions.

  3. Blinding assessment

    Time frame: week 12

    Participants will be asked the following question: do you think you have received traditional acupuncture in the past weeks?

  4. Safety assessment

    Time frame: week 0 to week 52

    Adverse events and severe adverse events will be recorded in the case report form, whether related to interventions ol not.

  5. Adherence assessment of acupuncture

    Time frame: weeks 1 to week 12

    Adherence will be assessed via counting treatment sessions. Those who complete over 80% treatment sessions will be defined as of good adherence.

  6. Adherence assessment of life modification

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

    Adherence will be assessed through dietary diaries and physical activity questionnaires.

Study contacts

Contact information is provided by the study sponsor or research team.

Yan Yan

CONTACT

[email protected]

+8618579122011

Zhishun Liu, PhD

CONTACT

[email protected]

86-010-88002331

Sponsors and collaborators

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Other

Collaborators

  • Dongfang Hospital Beijing University of Chinese Medicine
  • Guangdong Provincial Hospital of Chinese Medicine, Zhuhai
  • Heilongjiang Academy of traditional Chinese Medicine
  • Hubei Hospital of Traditional Chinese Medicine
  • Linyi Hospital of Traditional Chinese Medicine
  • Qingdao Traditional Chinese Medicine Hospital
  • Shaanxi Hospital of Traditional Chinese Medicine
  • The Affiliated Hospital of Qingdao University
  • The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
  • The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
  • Xi'an Hospital of Traditional Chinese Medicine
  • Xi'an Traditional Chinese Medicine Hospital
  • Yantai Penglai Traditional Chinese Medicine Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 11, 2024
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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