Acupuncture for Obesity With Prediabetes

Not Applicable

Not yet recruiting

• Conditions: Obesity; Pre-diabetes
• Interventions: Device: Sham acupuncture; Device: Acupuncture

• Registration Number: NCT06359418
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Brief Summary

The clinical trial aims to evaluate the efficacy and safety of acupuncture on weight loss and changes of glucose and lipid metabolism in obese adults with pre-diabetes.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-24
• Study First Submitted QC: 2024-04-05
• Last Update Submitted: 2024-04-05
• Study Start: 2024-04-10
• Study First Posted: 2024-04-11
• Last Update Posted: 2024-04-11
• Primary Completion: 2026-12-10
• Study Completion: 2027-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

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

1. Meet the diagnostic criteria of obesity and pre-diabetes;
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham acupuncture	Sham acupuncture	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).
Acupuncture	Acupuncture	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).

Primary Outcome Measures

Name	Time	Method
The percentage change in body weight from baseline to week 12	week 12	The weight is measured by electronic scale with an accuracy of 0.1kg.

Secondary Outcome Measures

Name	Time	Method
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	A 5% reduction is the weight loss target for obese patients recommended in most guidelines.
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	A 7% reduction is a weight loss target for obese patients with other metabolic diseases recommended in most guidelines.
The change in 1hPG from baseline and percentage of patients who returned to normal	week 12, week 36	1hPG, 1-hour post-load Plasma Glucose, will be measured by oral glucose tolerance test, in mmol/L.
The change in FPG from baseline and percentage of patients who returned to normal	week 12, week 36	FPG is fasting plasma glucose, the result will be reported in mmol/L.
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	The weight is measured by electronic scale with an accuracy of 0.1kg.
The change in 2hPG from baseline and percentage of patients who returned to normal	week 12, week 36	2hPG, 2-hour post-load Plasma Glucose, will be measured by oral glucose tolerance test, in mmol/L.
The change in HbA1c from baseline and percentage of patients who returned to normal	week 12, week 36	HbA1c is glycated haemoglobin, the result will be reported in percentage (%) units.
The change in BMI from baseline	week 4, week 8, week 12, week 16, week 24, week 36	BMI=Body Mass Index, weight and height will be combined to report BMI in kg/m\^2.
The change in waist circumference from baseline	week 4, week 8, week 12, week 16, week 24, week 36	Waist circumference measurements are accurate to 0.1cm.
The change in WHR from baseline	week 4, week 8, week 12, week 16, week 24, week 36	WHR=Waist-to-Hip Ratio, the ratio of waist to hip circumference, waist and hip circumference are accurate to 0.1cm.
The change in WHtR from baseline	week 4, week 8, week 12, week 16, week 24, week 36	WHtR=waist-to-Height Ratio, the ratio of waist circumference to height. Both are in cm units, accurate to 0.1cm.
The change in blood pressure from baseline	week 4, week 8, week 12, week 16, week 24, week 36	Record the values of systolic blood pressure and diastolic blood pressure in mmHg.
Changes in appetite VAS score from baseline	week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 32, week 36	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.
The change in FINS from baseline	week 12, week 36	FINS is fasting insulin, the result will be reported in pmol/L.
The change in HOMA-IR from baseline	week 12, week 36	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/225.
The change in HOMA-β from baseline	week 12, week 36	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).
The change in Serum total cholesterol from baseline	week 12, week 36	The Serum total cholesterol will be reported in mmol/L.
The change in Triglyceride from baseline	week 12, week 36	The Triglyceride will be reported in mmol/L.
The change in Serum Uric Acid from baseline	week 12, week 36	The Serum Uric Acid will be reported in μmol/L.
The change in Low-Density Lipoprotein Cholesterol from baseline	week 12, week 36	The Low-Density Lipoprotein Cholesterol will be reported in mmol/L.
Changes of the score of the European five-dimensional Health scale (EQ-5D-5L) compared with the baseline.	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.
The change in High-Density Lipoprotein Cholesterol from baseline	week 12, week 36	The High-Density Lipoprotein Cholesterol will be reported in mmol/L.
Changes of the PHQ-4 score from the baseline.	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.

Trial Locations

Locations (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, China