Acupuncture for Obesity With Prediabetes

Acupuncture for Obese Adults With Prediabetes: a Multicenter Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Pre-diabetes
• Intervention / Treatment: Device: Acupuncture; Device: Sham acupuncture

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhishun Liu, PhD; Phone Number: 86-010-88002331; Email: zhishunjournal@163.com
• Study Contact Backup: Name: Yan Yan; Phone Number: +8618579122011; Email: yanyanxuexi@163.com

Study Locations

• China
  • Beijing, China
    • Guang'anmen Hospital, China Academy of Chinese Medical Sciences
    • Contact: Zhishun Liu, PhD; Phone Number: +861088002331; Email: zhishunjournal@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: Acupuncture; 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 Comparator: 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).	Device: Sham acupuncture; The acupuncture needle (size 0.20x25mm) will be inserted into all acupoints at the depth of 2mm without any manipulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage change in body weight compared to the baseline	The weight is measured by electronic scale with an accuracy of 0.1kg.	week 4, week 8, week 16, week 20, week 24, week 28, week 32, week 36
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.	week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 32, week 36
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.	week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 32, week 36
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.	week 12, week 36
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.	week 12, week 36
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.	week 12, week 36
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.	week 12, week 36
The change in waist circumference from baseline	Waist circumference measurements are accurate to 0.1cm.	week 4, week 8, week 12, week 16, week 24, week 36
The change in BMI from baseline	BMI=Body Mass Index, weight and height will be combined to report BMI in kg/m^2.	week 4, week 8, week 12, week 16, week 24, week 36
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.	week 4, week 8, week 12, week 16, week 24, week 36
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.	week 4, week 8, week 12, week 16, week 24, week 36
The change in blood pressure from baseline	Record the values of systolic blood pressure and diastolic blood pressure in mmHg.	week 4, week 8, week 12, week 16, week 24, week 36
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.	week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 32, week 36
The change in FINS from baseline	FINS is fasting insulin, the result will be reported in pmol/L.	week 12, week 36
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/225.	week 12, week 36
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).	week 12, week 36
The change in Serum total cholesterol from baseline	The Serum total cholesterol will be reported in mmol/L.	week 12, week 36
The change in Triglyceride from baseline	The Triglyceride will be reported in mmol/L.	week 12, week 36
The change in Low-Density Lipoprotein Cholesterol from baseline	The Low-Density Lipoprotein Cholesterol will be reported in mmol/L.	week 12, week 36
The change in High-Density Lipoprotein Cholesterol from baseline	The High-Density Lipoprotein Cholesterol will be reported in mmol/L.	week 12, week 36
The change in Serum Uric Acid from baseline	The Serum Uric Acid will be reported in μmol/L.	week 12, week 36
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.	week 12, week 36
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.	week 12, week 36

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expectance assessment	Participants will be asked the following question: What do you think will happen to your obesity and prediabetes in 3 months?	baseline
Assessment of belief in acupuncture	Participants will be asked to answer "do you think acupuncture is helpful for obesity and prediabetes?" And three other related questions.	baseline
Blinding assessment	Participants will be asked the following question: do you think you have received traditional acupuncture in the past weeks?	week 12
Safety assessment	Adverse events and severe adverse events will be recorded in the case report form, whether related to interventions ol not.	week 0 to week 36
Adherence assessment of acupuncture	Adherence will be assessed via counting treatment sessions. Those who complete over 80% treatment sessions will be defined as of good adherence.	weeks 1 to week 12
Adherence assessment of life modification	Adherence will be assessed through dietary diaries and physical activity questionnaires.	week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 32, week 36

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Collaborators: Guangdong Provincial Hospital of Traditional Chinese Medicine; Hubei Hospital of Traditional Chinese Medicine; Dongfang Hospital Beijing University of Chinese Medicine; The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine; Heilongjiang Academy of traditional Chinese Medicine
• Investigators: Principal Investigator: Zhishun Liu, PhD, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): April 10, 2024
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): March 30, 2027

Study Registration Dates

• First Submitted: March 24, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; randomized controlled trial; acupuncture; Pre-diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Hyperglycemia; Obesity; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: 2024-007-KY

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No