The investigators describe a protocol for a randomized controlled trial to find out the effect and safety of electroacupuncture on losing weight in obese patients with prediabetes.
Obesity has emerged as a contributing factor in diabetes mellitus. In 2015, about 4 million deaths worldwide were directly related to high BMI, accounting for 7.1% of all deaths; among them, 41% died due to cardiovascular disease, followed by diabetes mellitus. China has become the country with the largest number of obese people and diabetic patients in the world. According to the clinical practice guidelines for medical care of obese patients announced by AACE and ACE, obese patients with prediabetes can effectively prevent the development of diabetes by lose 10% or more than of their body weight. Acupuncture is a widely recognized therapy to lose weight in clinical practice. But there are some doubts about the effectiveness of acupuncture versus sham acupuncture in treating obesity due to its lack of medical evidence. This randomized placebo-controlled clinical trial is aimed to investigate the effect and safety of Electroacupuncture (EA) in obese patients with prediabetes. The investigators designed a protocol for a randomized controlled trial, in which 256 eligible patients will be randomly assigned to one of the two groups in a ratio of 1:1, the EA group (receiving EA treatment with health education) and the sham electroacupuncture (SA) group (receiving superficial acupuncture treatment with health education). A total of 56 sessions of interventions will be given for consecutive 24 weeks, followed by a 24-week follow-up period. Each session of EA or SA treatment will last for about 30 minutes. The primary outcome is the proportion of patients who lost 10% or more than of their body weight at week 24. The secondary outcomes include the change of patient's body weight and body mass index (BMI), results from the blood tests (FBG, 2hPG, HbA1c, HOMA-IR, LDL-C, HDL-C, TG and TC, ect.), the fat tissue size scanned by abdominal magnetic resonance imaging (MRI), data collected from the body composition analyzer, the and scores of the impact of weight on quality of life (IWQOL-Lite), Three Factor Eating Questionnaire - R21 (TFEQ-R21) and Food Cravings Questionnaire-Trait (FCQ-T). All adverse effects will be accessed by the Treatment Emergent Symptom Scale (TESS) from baseline to the follow-up period. The body weight and BMI will be calculated at baseline, week 8, week 16, week 24, week 32, week 40 and week 48, as well as the IWQOL-Lite, the TFEQ-R21 and the FCQ-T. Blood tests will be analyzed at baseline and week 24, as well as the body composition analyzer and the MRI scan. All patients will be provided with the same health education brochure to choose more beneficial personalized lifestyle during the 24-week intervention period. All analyses will be performed on the intention-to-treat (ITT) population of participants who have at least one treatment. Missing data will be handled using the multiple imputation method, on the assumption that values at each time point follow a specific distribution calculated by the computer software R V.3.5. The primary analysis will be a comparison of the proportion of patients who losing 10% or more than of their body weight between the two groups at 24 weeks after inclusion (comparison of the primary endpoint). Linear mixed-effects models will be used for analyses with the use of the statistical software SPSS V.20.0. The t-test will be used to compare the measurement data between either two groups from the baseline to follow-up; the rank sum test will be used for ranked data while the Chi-squared test will be used to analyze categorical data. The significance level that will be used for statistical analysis with 2-tailed testing will be 2.5%. Data values will mainly be presented as Mean±SD. The findings from this trial will help further explore the efficacy and safety of EA on losing weight for patients with obesity and prediabetes, as well as determine the differences between the EA and SA treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
256
Regular acupuncture will be applied at the main and the additional acupoints with 0.25mm\*40mm or 0.30mm\*75mm needles. The main acupoints include Shangwan (CV13), Zhongwan (CV12), Jianli (CV11), Xiawan (CV10), bilateral Quchi (LI11), Hegu (LI4), Liangmen (ST21), Tianshu (ST25), Daheng (SP15), Fujie (SP14), Shuidao (ST28), Zusanli (ST36), Fenglong (ST40), Wailing (ST26), Guilai (ST29). Additional acupoints include bilateral Shangjuxu (ST37) and Neiting (ST44), bilateral Yinlingquan (SP9) and Shuifen (CV9), Qihai (CV6) and Guanyuan (CV4). Acupuncturists will use all main acupoints and choose the combined acupoints based on the patients' patterns during each treatment session. The EA apparatus will be connected to the needles at the bilateral ST21, ST25, SP15, using continuous wave type, frequency at 3 Hz, and intensity of 4-5 mA based on the endurance of each patient. Needles will be retained for 30 minutes before removal.
Patients will receive superficial acupuncture treatment at the same main acupoints as EA group with 0.22\*0.25mm needles. The electroacupuncture apparatus will connected to the needles at the bilateral Liangmen (ST21), Tianshu (ST25), Daheng (SP15) without current output. Needles will be retained for 30 minutes before removal. The treatment will be given 3 times a week in week 1-12, 2 times a week in week 13-20, and once a week in week 21-24, totaling 56 sessions of real or sham acupuncture.
Shanghai Municipal Hospital of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGThe Percentage of patients who lost 10% of their body weight
We will calculate the proportion of people in each group who lost 10% or more of their baseline body weight at the end of the intervention period.
Time frame: week 24
Changes of body weight from baseline to week 48
The change of body weight is an important factor of the development of diabetes. We will calculate the mean weight change in each group of patients during the intervention and follow-up period, compared with baseline data.
Time frame: baseline, week 8, week 16, week 24, week 32, week 40 and week 48
Changes of BMI from baseline to week 48
BMI is a statistical index using a person's weight and height to provide an estimate of body fat in males and females of any age. It is calculated by taking a person's weight, in kilograms, divided by their height, in meters squared, or BMI = weight (kg)/ height2 (m2). BMI is used to define a person as underweight, normal weight, overweight, or obese by the National Institute of Health (NIH).
Time frame: baseline, week 8, week 16, week 24, week 32, week 40 and week 48
Change of blood glucose from baseline to week 24
It is the concentration of glucose in the blood, including fasting plasma glucose (FBG) which reflects function of islet β cell and 2 hour postprandial blood glucose (2hPG) which reflects the reserve function of islet β cell.
Time frame: baseline, week 24
Change of HbA1c from baseline to week 24
HbA1c reflects the average blood glucose level of diabetic patients in the past 8-12 weeks. HbA1c≥5.5% indicates the presence of insulin resistance, and ≥6.5% indicates the occurrence of diabetes.
Time frame: baseline, week 24
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The health management brochure will be distributed to all patients in the trial after enrollment, and health education will be arranged online or offline at week 4, 8, 12, 16, 20 and 24 for about 60 minutes, including lifestyle, diet and physical activity. According to the specific situation of each patient, healthier individual lifestyle and behavior will be recommended to all patients, but there will be no strict restrictions on the diet or physical activity.
Change of insulin resistance index (HOMA-IR) from baseline to week 24
HOMA-IR is one of the most common formulas to reflect the intensity of insulin resistance. The higher index indicates the more serious insulin resistance. Insulin resistance index (HOMA-IR) = fasting insulin (FINS)\*fasting plasma glucose (FPG)/22.5, HOMA-IR \> 1 indicates the presence of insulin resistance.
Time frame: baseline, week 24
Change of blood lipid from baseline to week 24
Blood lipid includes low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), triglyceride (TG), and total cholesterol (TC), which reflects the internal lipid metabolism of whole body.
Time frame: baseline, week 24
Change of fat and muscle mass from baseline to week 24
The non-invasive body composition analyzer (Inbody 770) of the Inbody company can be used to measure high density body composition through bioelectrical impedance analysis, including body fat mass and skeletal muscle mass. The body fat mass reveals how much body fat makes up the weight, both surface level (subcutaneous) and internal (visceral). skeletal muscle mass is the muscle that can be grown and developed through exercise. And the muscle-fat analysis tells you whether you have a healthy balance of SMM and Body Fat Mass in respect to your weight.
Time frame: baseline, week 24
Change of percentage body fat from baseline to week 24
The non-invasive body composition analyzer (Inbody 770) of the Inbody company can be used to measure high density body composition through bioelectrical impedance analysis, including percent body fat. Body fat percentage is a division of the participant's body fat mass by his/her total weight and a much better indicator of the risk of obesity than BMI.
Time frame: baseline, week 24
Change of basal metabolic rate from baseline to week 24
The non-invasive body composition analyzer (Inbody 770) of the Inbody company can be used to measure high density body composition through bioelectrical impedance analysis, including the basal metabolic rate. BMR is the calories that one person needs for the basic essential functions. It allows the individual to work with the dietician to create a nutritional plan, which is key to reaching the body composition goals.
Time frame: baseline, week 24
Change of fat tissue size from baseline to week 24
Abdominal magnetic resonance imaging (MRI) scan will be used to scan the upper abdomen and flat umbilical layer to quantitatively calculate abdominal fat size and the ratio of intra-abdominal and subcutaneous fat size.
Time frame: baseline, week 24
Impact of weight on quality of life (IWQOL-Lite)
It is a 31-item self-report questionnaire measuring the quality of life of obese patients (or those with type 2 diabetes). it consists of the following 5 dimensions: physical functioning, self-esteem, sexual life, public stress, and work included.
Time frame: baseline, week 8,16, 24, 32, 40 and week 48
Three Factor Eating Questionnaire-R21(TFEQ-R21)
TFEQ is one of the most widely used instruments to study different eating behaviors. It assesses three cognitive and behavioral domains of eating: cognitive restraint (6 items), uncontrolled eating (9 items) and emotional eating (6 items). It comprises 21 items in a four-point Likert scale for items 1-20 and on an eight-point numerical rating scale for item 21. Responses to each of the items are given a score between 1 and 4. Before calculating domain scores, items 1-16 were reverse coded and item 21 was recoded as follows: 1-2 scores as 1; 3-4 as 2; 5-6 as 3; 7-8 as 4.
Time frame: baseline, week 8,16, 24, 32, 40 and week 48
Food Cravings Questionnaire-Trait (FCQ-T)
It measures the frequency and intensity of food craving experiences in patients. The questionnaire has 39 items and response categories range from 1 = never to 6 = always. There are no inverted items. Responses to all items are summed up for a total score. Higher scores represent more frequent and intense food cravings.
Time frame: baseline, week 8,16, 24, 32, 40 and week 48