NCT06359418招募中不适用
Acupuncture for Prediabetes With Combined Obesity: a Multicenter Randomized Controlled Trial
Guang'anmen Hospital of China Academy of Chinese Medical Sciences1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2025年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- The percentage change in body weight from baseline to week 12
研究概览
简要总结
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.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are eligible to be included in the trial only if all of the following criteria apply:
- •Simultaneously meeting the diagnostic criteria for both general obesity, abdominal obesity, and prediabetes;
- •Aged 18-64 years old;
- •Informed consent obtained before any trial-related activities.
排除标准
- •Subjects are excluded from the trial if any of the following criteria apply:
- •Obesity of known endocrine origin (e.g., untreated hypothyroidism, Cushing's syndrome, established Polycystic Ovary Syndrome);
- •impaired glucose regulation due to hyperthyroidism, endocrine tumors and extensive liver damage;
- •Diagnosis of type 1 or type 2 diabetes per the judgment of the investigator;
- •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;
- •History of pancreatitis or pancreatectomy;
- •Previous or planned (during the trial period) obesity treatment with surgery or a weight-loss device;
- •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);
- •A self-reported change in body weight >5 kg within 3 months before screening irrespective of medical records;
- •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;
- •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;
- •Skin infection, blood coagulation disorders and other conditions that are not suitable for acupuncture;
- •Metal allergies or severe fear of needles;
- •Pregnant or breast-feeding women or planning to become pregnant during the study period;
- •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.
结局指标
主要结局
The percentage change in body weight from baseline to week 12
时间窗: week 12
The weight is measured by electronic scale with an accuracy of 0.1kg.
The percentage change in body weight from baseline to week 12
时间窗: week 12
The weight is measured by electronic scale with an accuracy of 0.1kg.
The percentage change in waist circumference from baseline to week 12
时间窗: week 12
The waist circumference is measured by a fiberglass tape measure with an accuracy of 0.1 centimeters.
次要结局
- Changes of the PHQ-4 score from the baseline.(week 12, week 36)
- Changes of the score of the European five-dimensional Health scale (EQ-5D-5L) compared with the baseline.(week 12, week 36)
- The percentage change in body weight compared to the baseline(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(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(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(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(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(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(week 12, week 36, week 52)
- The proportion of participants developing diabetes(week 12, week 36, week 52)
- The change in 2hPG from baseline and percentage of patients who returned to normal(week 12, week 36, week 52)
- The change in FPG from baseline and percentage of patients who returned to normal(week 12, week 36, week 52)
- The change in HbA1c from baseline and percentage of patients who returned to normal(week 12, week 36, week 52)
- The change in 1hPG from baseline and percentage of patients who returned to normal(week 12, week 36, week 52)
- Changes in appetite VAS score from baseline(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(week 4, week 8, week 12, week 16, week 24, week 36, week 52)
- The change in WHR from baseline(week 4, week 8, week 12, week 16, week 24, week 36, week 52)
- The change in WHtR from baseline(week 4, week 8, week 12, week 16, week 24, week 36, week 52)
- The change in FINS from baseline(week 12, week 36, week 52)
- The change in HOMA-IR from baseline(week 12, week 36, week 52)
- The change in HOMA-β from baseline(week 12, week 36, week 52)
- The change in Serum total cholesterol from baseline(week 12, week 36, week 52)
- The change in Triglyceride from baseline(week 12, week 36, week 52)
- The change in Low-Density Lipoprotein Cholesterol from baseline(week 12, week 36, week 52)
- The change in High-Density Lipoprotein Cholesterol from baseline(week 12, week 36, week 52)
- The change in Serum Uric Acid from baseline(week 12, week 36, week 52)
- The change in C-reactive protein from baseline(week 12, week 36, week 52)
- The change in blood pressure from baseline(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.(week 12, week 36)
- Changes of the PHQ-4 score from the baseline.(week 12, week 36)
研究者
Liu Zhishun
Principal Investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
研究点 (1)
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