Clinical trial NCT05237089: Effect of Electroacupuncture on Obesity
Official title: Effects of Electroacupuncture on Weight Loss in Obese Patients With Prediabetes: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Electroacupuncture
Obesity
Prediabetes
Sham acupuncture
Randomized Controlled Trial
Lead sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All eligible participants will be randomly assigned into two group at a ratio of 1:1, the Electroacupuncture group and the Sham acupuncture group (the control group).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Male or female participants aged 18-65;
2. Participant whose BMI is ≥24.0 kg/m2;
3. Participants whose HbA1c measurement of 5.7-6.4% both inclusive, or fasting plasma glucose measurement ≥ 6.1 mmol/liter and \<7.0 mmol/liter, or 2-hour plasma glucose measurement post-challenge (oral glucose tolerance test) ≥7.8 mmol/liter and \<11.1 mmol/liter;
4. Participants with stable weight within 3 months before the start of the trial, fluctuated within 4 kg;
5. Participants who voluntarily agree with the investigation and sign a written informed consent form for the clinical trial.

Exclusion Criteria:

1. Patients with secondary obesity caused by drugs or neuro-endocrine-metabolic disorders (such as hypothalamic disease and hypopituitarism);
2. Patients who have been diagnosed with type I or type II diabetes;
3. Patients who are taking medication which cause clinically significant weight gain or loss;
4. Patients whose Hamilton 17-item Depression Scale (HAMD-17) score \>18 or have a history of other severe psychiatric disorders;
5. Patients with severe ulcer, abscess and skin infection at the local acupuncture area;
6. Patients with severe diseases of multiple organs, such as heart, brain, lungs, liver, kidneys, hematopoietic system or other serious diseases;
7. Participants who have joined in other clinical trials or studies within the past 1 month;
8. Pregnant or lactating women.

Primary outcomes:
measure: The Percentage of patients who lost 10% of their body weight
timeFrame: week 24
Secondary outcomes:
measure: Changes of body weight from baseline to week 48
timeFrame: baseline, week 8, week 16, week 24, week 32, week 40 and week 48
measure: Changes of BMI from baseline to week 48
timeFrame: baseline, week 8, week 16, week 24, week 32, week 40 and week 48
measure: Change of blood glucose from baseline to week 24
timeFrame: baseline, week 24
measure: Change of HbA1c from baseline to week 24
timeFrame: baseline, week 24
measure: Change of insulin resistance index (HOMA-IR) from baseline to week 24
timeFrame: baseline, week 24
measure: Change of blood lipid from baseline to week 24
timeFrame: baseline, week 24
measure: Change of fat and muscle mass from baseline to week 24
timeFrame: baseline, week 24
measure: Change of percentage body fat from baseline to week 24
timeFrame: baseline, week 24
measure: Change of basal metabolic rate from baseline to week 24
timeFrame: baseline, week 24
measure: Change of fat tissue size from baseline to week 24
timeFrame: baseline, week 24
measure: Impact of weight on quality of life (IWQOL-Lite)
timeFrame: baseline, week 8,16, 24, 32, 40 and week 48
measure: Three Factor Eating Questionnaire-R21(TFEQ-R21)
timeFrame: baseline, week 8,16, 24, 32, 40 and week 48
measure: Food Cravings Questionnaire-Trait (FCQ-T)
timeFrame: baseline, week 8,16, 24, 32, 40 and week 48
Other outcomes:
measure: Adverse effects
timeFrame: from baseline to week 48
Locations:
city: Shanghai
country: China
facility: Shanghai Municipal Hospital of Traditional Chinese Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Municipal Hospital of Traditional Chinese Medicine
name: Shifen Xu, PhD
role: STUDY_DIRECTOR
References: