NCT07103382招募中不适用
Efficacy and Safety of Attapulgite in Patients With Obesity: An Exploratory Clinical Trial
Second Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年6月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- BMI (Body Mass Index)
研究概览
简要总结
To explore the safety and efficacy of attapulgite in the treatment of obese individuals or overweight/obese individuals with type 2 diabetes.
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
- Double (Participant, Investigator)
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
- •Obese individuals:
- •Aged 18-60 years, regardless of sex/gender
- •BMI≥28.0kg/m2
- •Overweight or obese individuals with type 2 diabetes:
- •Aged 18-60 years, regardless of sex/gender
- •BMI≥24.0kg/m2
- •HbA1c ≥7.0% and ≤10.0% or the fasting blood glucose ≥7.0 mmol/l and ≤ 13.3 mmol/l at screening
- •Stable diabetes treatment for at least 6 months or more
排除标准
- •Type 1 diabetes, monogenic diabetes, or diabetes due to pancreatic injury or other secondary diabetes
- •Severe diabetic complications within three months before the study initiation, including severe hypoglycemia, diabetic ketoacidosis, or infections
- •Use of weight-affecting products within the past three months or planned use during the study
- •Weight fluctuation >5 kg or >10% within the past three months
- •Obesity or overweight due to endocrine disorders (such as thyroid dysfunction or Cushing's syndrome)
- •Uncontrolled hypertension, severe cardiac/hepatic/renal dysfunction
- •History of gastrointestinal surgery (such as cholecystectomy) within the past year or non-gastrointestinal surgery within six months, or prior bariatric surgery
- •Chronic gastrointestinal disorders (such as recurrent constipation, celiac disease, or food intolerances) or any condition impairing digestion/absorption function
- •History of malignant tumors within five years, regardless of whether there is recurrence or metastasis and severe immune dysfunction (such as malignant tumors, HIV/AIDS, immunodeficiency diseases)
- •Use of probiotics, prebiotics, or antibiotics within three months prior to enrollment, or alcohol abuse; Consumption of yogurt within two weeks before the study or during the trial period; History of psychiatric or infectious diseases
- •Pregnancy, lactation, or plans for pregnancy during the study
- •Participation in other clinical trials within the past three months
- •Any condition that in the judgement of the investigator precludes participation
研究组 & 干预措施
Placebo
Placebo Comparator
Maltodextrin capsules (0.4-0.5 g) were administered at a dose of 3 capsules twice daily for 12 weeks.
干预措施: Placebo (Dietary Supplement)
Attapulgite
Experimental
Attapulgite capsules (0.4-0.5 g) were administered at a dose of 3 capsules twice daily for 12 weeks.
干预措施: Attapulgite (Dietary Supplement)
结局指标
主要结局
BMI (Body Mass Index)
时间窗: "Baseline" "6 weeks" and "12 weeks"
BMI used to assess body weight relative to height, the unit of BMI is kg/m² (kilograms per square meter).
次要结局
- Human basal metabolic rate("Baseline" and "12 weeks")
- Visceral fat mass("Baseline" and "12 weeks")
- Subcutaneous fat area("Baseline" and "12 weeks")
- Serum triglycerides("Baseline" "6 weeks" and "12 weeks")
- Serum total cholesterol("Baseline" "6 weeks" and "12 weeks")
- Serum LDL-c("Baseline" "6 weeks" and "12 weeks")
- Serum HDL-c("Baseline" "6 weeks" and "12 weeks")
- Gut microbiome("Baseline" and "12 weeks")
- Hip circumference("Baseline" "6 weeks" and "12 weeks")
- Waist-to-hip ratio("Baseline" "6 weeks" and "12 weeks")
- Human body fat percentage("Baseline" and "12 weeks")
- Weight("Baseline" "6 weeks" and "12 weeks")
- Waist circumference("Baseline" "6 weeks" and "12 weeks")
- Gut metabolites("Baseline" and "12 weeks")
- Serum metabolites("Baseline" and "12 weeks")
- Fasting serum C peptide levels("Baseline" "6 weeks" and "12 weeks")
- Fasting serum insulin levels("Baseline" "6 weeks" and "12 weeks")
- Glycated albumin("Baseline" "6 weeks" and "12 weeks")
- Glycated haemoglobin (HbA1c)("Baseline" "6 weeks" and "12 weeks")
- 2-hour serum C peptide levels("Baseline" and "12 weeks")
- 2-hour serum insulin levels("Baseline" and "12 weeks")
- 2-hour blood glucose levels("Baseline" and "12 weeks")
- HOMA-IR (Homeostatic Model Assessment of Insulin Resistance)("Baseline" "6 weeks" and "12 weeks")
- Inflammation markers("Baseline" "6 weeks" and "12 weeks")
- Hepatic function("Baseline" "6 weeks" and "12 weeks")
- Adverse events(12 weeks)
- 2-hour serum insulin levels("Baseline" and "12 weeks")
- 2-hour blood glucose levels("Baseline" and "12 weeks")
- Inflammation markers("Baseline" "6 weeks" and "12 weeks")
- Hepatic function("Baseline" "6 weeks" and "12 weeks")
- Weight("Baseline" "6 weeks" and "12 weeks")
- Subcutaneous fat area("Baseline" and "12 weeks")
- Serum HDL-c("Baseline" "6 weeks" and "12 weeks")
- Gut microbiome("Baseline" and "12 weeks")
- Waist circumference("Baseline" "6 weeks" and "12 weeks")
- Hip circumference("Baseline" "6 weeks" and "12 weeks")
- Waist-to-hip ratio("Baseline" "6 weeks" and "12 weeks")
- Human body fat percentage("Baseline" and "12 weeks")
- Human basal metabolic rate("Baseline" and "12 weeks")
- Visceral fat mass("Baseline" and "12 weeks")
- Serum triglycerides("Baseline" "6 weeks" and "12 weeks")
- Serum total cholesterol("Baseline" "6 weeks" and "12 weeks")
- Serum LDL-c("Baseline" "6 weeks" and "12 weeks")
- Fasting blood glucose("Baseline" "6 weeks" "12 weeks")
- Glycated albumin("Baseline" "6 weeks" and "12 weeks")
- Glycated haemoglobin (HbA1c)("Baseline" "6 weeks" and "12 weeks")
- 2-hour serum C peptide levels("Baseline" and "12 weeks")
- Gut metabolites("Baseline" and "12 weeks")
- Serum metabolites("Baseline" and "12 weeks")
- Fasting serum C peptide levels("Baseline" "6 weeks" and "12 weeks")
- Fasting serum insulin levels("Baseline" "6 weeks" and "12 weeks")
- HOMA-IR (Homeostatic Model Assessment of Insulin Resistance)("Baseline" "6 weeks" and "12 weeks")
- Serum urea nitrogen("Baseline" "6 weeks" and "12 weeks")
- Serum creatinine("Baseline" "6 weeks" and "12 weeks")
- Serum urinary acid("Baseline" "6 weeks" and "12 weeks")
- Adverse events(12 weeks)
研究者
Yang Xiao
Associate Professor, Department of Metabolism and Endocrinology, Institute of Metabolism and Endocrinology, National Clinical Research Center for Metabolic Diseases, Second Xiangya Hospital, Central South University
Second Xiangya Hospital of Central South University
研究点 (1)
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