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| Name | Class |
|---|---|
| Hubei Hospital of Traditional Chinese Medicine | OTHER |
| Guangdong Provincial Hospital of Chinese Medicine, Zhuhai | UNKNOWN |
| The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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 |
| 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 |
| 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, week 52 |
| The percentage change in waist circumference compared to the baseline |
| 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. |
Inclusion Criteria:
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Subjects are eligible to be included in the trial only if all of the following criteria apply:
Exclusion Criteria:
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Subjects are excluded from the trial if any of the following criteria apply:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhishun Liu, PhD | Contact | 86-010-88002331 | zhishunjournal@163.com | |
| Yan Yan | Contact | +8618579122011 | yanyanxuexi@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhishun Liu, PhD | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'anmen Hospital, China Academy of Chinese Medical Sciences | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D056128 | Obesity, Abdominal |
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Dongfang Hospital Beijing University of Chinese Medicine | OTHER |
| Linyi Hospital of Traditional Chinese Medicine | UNKNOWN |
| The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine | UNKNOWN |
| Xi'an Traditional Chinese Medicine Hospital | OTHER |
| Qingdao Traditional Chinese Medicine Hospital | UNKNOWN |
| Xi'an Hospital of Traditional Chinese Medicine | OTHER |
| Heilongjiang Academy of traditional Chinese Medicine | UNKNOWN |
| The Affiliated Hospital of Qingdao University | OTHER |
| Yantai Penglai Traditional Chinese Medicine Hospital | OTHER |
| Shaanxi Hospital of Traditional Chinese Medicine | OTHER |
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| Sham acupuncture | Device | The acupuncture needle (size 0.20x25mm) will be inserted into all acupoints at the depth of 2mm without any manipulation. |
|
Waist circumference measurements are accurate to 0.1cm. |
| 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 | 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, week 52 |
| 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, week 52 |
| The change in body weight from baseline | The weight is measured by electronic scale with an accuracy of 0.1kg. | week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 32, week 36, week 52 |
| The change in waist circumference from baseline | Waist circumference measurements are accurate to 0.1cm. | week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 32, week 36, week 52 |
| The proportion of participants reverting to normoglycaemia | The determination is based on the results of blood glucose laboratory parameters. | week 12, week 36, week 52 |
| The proportion of participants developing diabetes | The determination is based on the results of blood glucose laboratory parameters. | week 12, week 36, week 52 |
| 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, week 52 |
| 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, week 52 |
| 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, week 52 |
| 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, week 52 |
| 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, week 52 |
| 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, week 52 |
| 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, week 52 |
| 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, week 52 |
| The change in FINS from baseline | FINS is fasting insulin, the result will be reported in pmol/L. | week 12, week 36, week 52 |
| 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. | week 12, week 36, week 52 |
| 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, week 52 |
| The change in Serum total cholesterol from baseline | The Serum total cholesterol will be reported in mmol/L. | week 12, week 36, week 52 |
| The change in Triglyceride from baseline | The Triglyceride will be reported in mmol/L. | week 12, week 36, week 52 |
| The change in Low-Density Lipoprotein Cholesterol from baseline | The Low-Density Lipoprotein Cholesterol will be reported in mmol/L. | week 12, week 36, week 52 |
| The change in High-Density Lipoprotein Cholesterol from baseline | The High-Density Lipoprotein Cholesterol will be reported in mmol/L. | week 12, week 36, week 52 |
| The change in Serum Uric Acid from baseline | The Serum Uric Acid will be reported in μmol/L. | week 12, week 36, week 52 |
| The change in C-reactive protein from baseline | The C-reactive protein will be reported in mg/L. | week 12, week 36, week 52 |
| 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, week 52 |
| 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 |
| 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 52 |
| 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, week 52 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |