Acupuncture for Impaired Glucose Tolerance in Overweight/Obese Population: a Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- The change in the value of 2-hour blood glucose from baseline at the end of the 12-week treatment
研究概览
简要总结
This is a prospective, multicenter, parallel-group, participants- and assessors-blinded randomized trial aiming to evaluate the effectiveness and safety of acupuncture in improving glucose metabolism for overweight/obese Participants with IGT, in comparison with sham acupuncture.
详细描述
The trial will be conducted at three hospitals in China. 196 eligible subjects will be randomly assigned (1:1) to the acupuncture or sham acupuncture group to receive either 30-session acupuncture/sham acupuncture treatment over 12 weeks based on lifestyle intervention and 24-week follow-up. The primary outcome is the change in the value of 2-hour blood glucose (2hPG) from baseline at the end of the 12-week treatment. Additionally, compliance, blinding, and safety will also be assessed. All statistical tests will be performed using a two-sided test, a p-value of less than 0.05 is considered significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •those who meet the diagnostic criteria of overweight/obesity and IGT:
- •①IGT: fasting blood glucose (PG) is lower than 7.0mmol/L, and 2-hour blood glucose (2hPG) after oral 75g glucose tolerance test (OGTT) is between 7.8~11.1mmol/L.
- •②overweight: 24.0 < BMI ≤ 27.9, obesity: BMI ≥ 28.0, or BMI ≤24.0 but Waist Circumference ≥85 cm (male) /≥80 cm(female).
- •18-60 years old;
- •those who can appropriately describe their wishes, voluntarily fill in the informed consent form and agree to participate in clinical trials.
排除标准
- •obesity secondary to heredity, drugs, and diseases;
- •those who have received weight-loss treatment including acupuncture and drugs in the past 3 months;
- •those who have taken drugs that have known effects on body weight or appetite in the past 3 months, such as corticosteroids, antidepressants, non-selective antihistamines in vivo, nicotine substitutes, etc;
- •IGT is caused by abnormal thyroid function, endocrine tumors, extensive liver damage;
- •abnormal glucose tolerance caused by thiazide diuretics, β-blockers, nicotinic acid drugs, quinolones, calcineurin inhibitors, interferon-alpha, etc;
- •received antidiabetic medicines in the past 3 months；
- •participants with serious primary diseases such as heart, lung, brain, liver, or hematopoietic system diseases, progressive malignant tumor, or other serious consumptive diseases;
- •Participants with cognitive impairment and severe mental illness;
- •participants with blood coagulation dysfunction, and scare of needles；
- •pregnant, breastfeeding, or planning to conceive within 37 weeks.
研究组 & 干预措施
Acupuncture Group
The acupuncture points are: EX-B3, BL18, BL20, BL21, GV20, GV29, LI11, CV12, CV10, ST25, CV6, CV4, ST40, SP6.
After piercing 15-35mm into the skin, the needles will be gently rotated and lifted three times to achieve a sense of sourness, distention, and heaviness (de qi). For EX-B3, BL18, BL20, and BL21, withdrawn afterward immediately. For GV20, GV29, LI11, CV12, CV10, ST25, CV6, CV4, ST40 and SP6, The needles will be maintained for 30 minutes.
干预措施: Acupuncture (Other)
Sham Acupuncture Group
sham acupoints are located at a horizontal distance of 20 mm to those points used in the acupuncture group, and no manipulation was carried out after piercing the skin for 1-2mm to avoid de-qi sensation.
For sham EX-B3, BL18, BL20, and BL21, withdraw immediately after piercing. For sham GV20, GV29, LI11, CV12, CV10, ST25, CV6, CV4, ST40 and SP6, The needles will be maintained for 30 minutes after puncture.
干预措施: Sham Acupuncture (Other)
结局指标
主要结局
The change in the value of 2-hour blood glucose from baseline at the end of the 12-week treatment
时间窗: week 12
The 2-hour blood glucose is the value of intravenous plasma glucose measured by oral 75g glucose tolerance test, which is usually used to diagnose impaired glucose tolerance and observe glucose metabolism.
次要结局
- The proportion of participants with at least 5% reductions in body weight from baseline(weeks 4, 8, 12, 16, 24 and 36)
- The proportion of participants whose 2-hour blood glucose dropped to normal from baseline(weeks 12, 24 and 36)
- The change from baseline in the SNAQ scores(weeks 4, 8, 12, 16, 24 and 36)
- The change from baseline of TC, TG, LDL-C, and HDL-C(weeks 12, 24 and 36)
- The change from baseline of body mass index(weeks 4, 8, 12, 16, 24 and 36)
- The change from baseline of Fasting serum insulin(weeks 12, 24 and 36)
- The change in the value of 2-hour blood glucose from baseline(weeks 24 and 36)
- The change from baseline of fasting plasma glucose(weeks 12, 24 and 36)
- The change from baseline of Homeostasis model assessment-insulin resistance(weeks 12, 24 and 36)
- The change from baseline of Waist-to-Hip Ratio(weeks 4, 8, 12, 16, 24 and 36)
- The change from baseline of blood pressure(weeks 12, 24 and 36)
- The change from baseline in the IWQOL-Lite scale scores(weeks 4, 8, 12, 16, 24 and 36)
研究者
Yan Yan
Principal Investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences