NCT05647915已完成4 期
Assess the Effects of Berberine in Reducing Abdominal Visceral Adipose Tissue Among Individuals with Obesity and Non-alcoholic Fatty Liver Disease
China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 337 人开始时间: 2023年7月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 337
- 试验地点
- 1
- 主要终点
- Change of visceral fat content
研究概览
简要总结
This multicenter, double-blinded, randomized controlled trial aims to evaluate the effect of berberine in reducing visceral and liver adipose tissue among individuals with obesity and non-alcoholic fatty liver disease (NAFLD) in China.
详细描述
The trial aims to evaluate the efficacy and safety of berberine treatment for obesity and NAFLD. Potential eligible patients will be recruited from 10-20 medical centers in China. After a 4-week run-in period with berberine, all the eligible participants will be randomized (1:1) to berberine 1.0 g per day plus lifestyle intervention (Arm A) or placebo plus lifestyle intervention (Arm B). The participants will be asked to attend the visit at least once every 2 months, and be followed up for 6 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Data manager and statistician
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged ≥18 years
- •Participants with obesity (i.e., BMI ≥ 28 kg/m2) and abdominal obesity (i.e., waist circumference ≥85 cm in female or waist circumference ≥90 cm in male)
- •Participants with NAFLD diagnosed by ultrasound, computed tomography or magnetic resonance imaging
排除标准
- •Patients with established coronary heart disease, stroke, or peripheral arterial disease
- •Patients diagnosed with diabetes or taking oral glucose-lowering drugs
- •Patients with severely uncontrolled hypertension (i.e., SBP≥180mmHg and/or DBP ≥110mmHg)
- •Excess alcohol consumption (i.e., alcohol ≥ 20 g/day in female or alcohol ≥ 30 g/day in male)
- •Other causes of fatty liver disease, including alcohol or drug abuse, hepatitis B or C, autoimmune, hepatolenticular degeneration, total parenteral nutrition, inflammatory bowel disease, celiac disease, hypothyroidism, Cushing syndrome, β -lipoprotein deficiency, lipid atrophy diabetes, Mauriac syndrome, etc.
- •Patients with thyroid disease, including hyperthyroidism or hypothyroidism
- •Patients with cardiac insufficiency
- •ALT or AST ≥ 3 times upper limit of normal, liver cirrhosis or hepatic insufficiency
- •Patients with renal insufficiency: estimated glomerular filtration rate (eGFR) < 60 ml/(min×1.73m2)
- •Patients who had weight loss surgery, or are currently taking drugs for weight loss, or plan to have weight loss surgery or drugs in the following 6 months
- •Patients diagnosed with glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •Taking berberine or drug containing berberine in the past 1 month
- •Any adverse reaction to berberine
- •Severe constipation, diarrhea, and/or severe chronic intestinal diseases (e.g., ulcerative colitis, Crohn's disease, irritable bowel syndrome, etc.)
- •Patients who had to use long-term or intermittent corticosteroids, immunosuppressants, antibiotics, or other drugs that affect inflammatory biomarkers
- •Women who are pregnant or breastfeeding, or those who plan to be pregnant during the trial
- •Patients with malignant tumors
- •Patients with mental disorders, cognitive disorders, and/or other serious diseases
- •Those who participated or have been participating other trials during the last 3 months
- •Any other conditions that may hinder the compliance to the study intervention or follow-up visit
研究组 & 干预措施
berberine group
Experimental
Berberine hydrochloride plus lifestyle intervention
干预措施: Berberine plus lifestyle intervention (Drug)
placebo group
Placebo Comparator
Placebo plus lifestyle intervention
干预措施: Placebo plus lifestyle intervention (Behavioral)
结局指标
主要结局
Change of visceral fat content
时间窗: 6 months
Measurement of visceral fat by computed tomography
Change of liver fat content
时间窗: 6 months
Measurement of liver fat content by computed tomography
次要结局
- Change of serum triglyceride(6 months)
- Change of fasting plasma glucose(6 months)
- Change of HbA1c(6 months)
- Change of 2-hour postprandial blood glucose(6 months)
- Change of homeostatic model assessment-insulin resistance(6 months)
- Change of homeostasis model assessment-insulin sensitivity(6 months)
- Change of high-density lipoprotein cholesterol(6 months)
- Change of total cholesterol(6 months)
- Change of lipoprotein (a)(6 months)
- Change of apolipoprotein(6 months)
- Change of metabolic syndrome z-score(6 months)
- Change of fat liver index(6 months)
- Change of body mass index(6 months)
- Change of waist-hip ratio(6 months)
- Change of systolic blood pressure(6 months)
- Change of diastolic blood pressure(6 months)
- Change of homeostasis model assessment-β cell(6 months)
- Change of serum homocysteine(6 months)
- Change of body weight(6 months)
- Change of waist-height ratio(6 months)
- Change of low-density lipoprotein cholesterol(6 months)
- Change of visceral fat index(6 months)
- Change of triglyceride glucose index(6 months)
- Change of serum urine acid(6 months)
- Normalization of glucose parameters among participants with prediabetes(6 months)
- Change of waist circumference(6 months)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
4 期
Effects of Berberine on Preventing Cardiovascular Disease and Diabetes MellitusPreDiabetesHypertensionNCT05749874China National Center for Cardiovascular Diseases2,024
已完成
2 期
Berberine as Adjuvant Treatment for Schizophrenia PatientsSchizophrenia Spectrum and Other Psychotic DisordersMetabolic Syndrome xSchizophreniaNCT02983188The University of Hong Kong113
Unknown
1 期
Effect of Berberine for Endothelial Function and Intestinal Microflora in Patients With Coronary Artery DiseaseStable Coronary Artery DiseasePercutaneous Coronary InterventionNCT04434365Peking Union Medical College Hospital24
招募中
不适用
A Clinical Trial to Assess the Efficacy and Tolerance of a Berberine-based Nutraceutical Formula to Aid Blood Sugar Regulation and MetabolismMetabolism DisorderNutraceuticalNCT06700915Ultimate International, Inc.80
已完成
不适用
Berberine Effects on Clinical Symptoms and Metabolic Disturbance in Patients With SchizophreniaTherapeuticsSchizophreniaNCT03548155Tianjin Anding Hospital65