Prospective Randomized Controlled Study on the Improvement of Body Weight Among Overweight and Obese Patients Through Different Smeglutide Administration Methods
概览
- 阶段
- 4 期
- 干预措施
- Semaglutide
- 疾病 / 适应症
- Weight Change, Body
- 发起方
- Huashan Hospital
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- weight change in kilograms
- 状态
- 尚未招募
- 最后更新
- 3年前
概览
简要总结
Investigators determined to detect the effect of smeglutide on body weight and metabolic indexes among overweight and obese participants through two different dosing programs.
详细描述
Participants will be randomized into either group. One group will start from 0.25mg per week for four weeks, then increase to 0.5mg per week for four weeks, and 1mg per week maintenance dose for 8 weeks. The other group dosage regime depends on the tolerance of the semaglutide from participants. The dosage will stabilize on the dose how much participant could tolerate. At the end of 16 weeks treatment, comparison will be carried out on weight change before and after treatment and (1) Comparison of different administration methods (standards and titrations) on participant compliance, appetite and quality of life improvement; (2) Comparison of metabolism (waist hip circumference, body fat and body composition, blood pressure, blood lipid, blood glucose, insulin resistance) in different administration modes; (3) Comparison of adverse reactions of metabolic drugs in different administration modes.
研究者
xiaolong zhao
Professor of endocrinology department
Shanghai Public Health Clinical Center
入排标准
入选标准
- •18 ≤ age\<75;
- •Overweight or obesity: meet either one of the following standards
- •Patients with BMI ≥ 24 kg/m2 and at least one obesity complication (hypertension, hyperlipidemia, apnea syndrome, cardiovascular disease)
- •Simple obese patients with BMI ≥ 28kg/m2
- •Abdominal obesity, waist circumference ≥ 90 cm for males and ≥ 80 cm for females
排除标准
- •Have a personal or family history of medullary thyroid carcinoma (MTC) or have multiple endocrine neoplasia type 2 (MEN-2) patients.
- •Patients with severe hypersensitivity to smeglutide or any other excipient component.
- •Diabetic patients (glycosylated hemoglobin ≥ 6.5% or fasting blood glucose ≥ 7.0 mmol/L or blood glucose ≥ 11.1 mmol/L 2 hours after meal or random blood glucose ≥ 11.1 mmol/L).
- •Triglyceride\>5.6mmol/L;
- •Participants in other clinical drug trials in recent three months.
- •The range of weight change in recent 90 days is\>5kg.
- •Cushing's syndrome and abnormal thyroid function.
- •Pregnant or breastfed women.
- •The study doctor judged that it was not suitable to participate in the test.
研究组 & 干预措施
standard arm
standard arm will start from 0.25mg per week for four weeks, then increase to 0.5mg per week for four weeks, and 1mg per week maintenance dose for 8 weeks..
干预措施: Semaglutide
titration arm
Titration arm dosage regime depends on the tolerance of the semaglutide from patients. The dosage will stabilize on the dose which patients could tolerate
干预措施: Semaglutide
结局指标
主要结局
weight change in kilograms
时间窗: 16 weeks
weight change in kilograms before and after treatment
次要结局
- waist hip circumference in centimeter(16 weeks)
- fasting blood glucose level(16 weeks)
- HOMA-Beta value(16 weeks)
- triglyceride(16 weeks)
- low-density lipoprotein cholesterol(16 weeks)
- high-density lipoprotein cholesterol(16 weeks)
- patient compliance in rate(16 weeks)
- number of adverse events(16 weeks)
- body fat in percentage(16 weeks)
- total cholesterol in mmol/L(16 weeks)
- appetite change in score(16 weeks)
- quality of life improvement in score(16 weeks)
- blood pressure in mmHg(16 weeks)
- blood lipid in concentration(16 weeks)
- body composition of lean mass in kilogram(16 weeks)