NCT07771166尚未招募不适用
Effects of N-Acyl Taurines on Incretin Levels in Healthy Subjects: a Randomised, Double-blind, Placebo-controlled, Cross-over Study
University Hospital, Gentofte, Copenhagen0 个研究点目标入组 18 人开始时间: 2027年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 18
- 主要终点
- Plasma glucagon-like peptide 1
研究概览
简要总结
This study is an investigator-initiated, randomised, double-blind, placebo-controlled, cross-over human trial investigating the effect of arachidonoyl-taurine (C20:4-taurine) and oleoyl-taurine (C18:1-taurine) on GLP-1 secretion during fasting and feeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 45 years
- •Body mass index between 18.5-27 kg/m2
- •Informed consent
- •Weight stable in the past 3 months
排除标准
- •Regular tobacco smoking or use of other nicotine-containing products
- •Allergy or intolerance to ingredients included in the test compounds or standardised meals
- •Glycated haemoglobin (HbA1c) >48 mmol/mol
- •Anaemia (haemoglobin below 8.3 mmol/L)
- •Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2 times upper normal values (Normal values: ALT < 70 U/L, AST <45 U/L)
- •Nephropathy (eGFR<90mL/min/1.73 m2) and/or albuminuria (>30 mg/g albumin in urine))
- •Women of childbearing potential who are not using effective contraception
- •Pregnancy or breastfeeding
- •History of hepatobiliary or gastrointestinal disorder(s)
- •Use of weight loss medication within the last 6 months
- •Any physical or psychological condition, or ongoing medication, that the investigator evaluates would interfere with trial participation, including any acute or chronic illnesses
结局指标
主要结局
Plasma glucagon-like peptide 1
时间窗: 0-360 minutes
Incremental area under curve 0-360 minutes
次要结局
- Plasma glucagon-like peptide 1(0-360 minutes)
- Gastric inhibitory polypeptide(0-360 minutes)
- C-peptide(0-360 minutes)
- Glucagon(0-360 minutes)
- N-acyl taurine species(0-360 minutes)
- Glucose(0-360 minutes)
- Visual analogue scale(0-360 minutes)
- Food intake(After 360 minutes)
- Paracetamol (gastric emptying)(180-360 minutes)
- Other glucose-regulating hormones/gut hormones(0-360 minutes)
- Free fatty acids(0-360 minutes)
- Cholesterol(0-360 minutes)
- Bile acids(0-360 minutes)
- Cholecystokinin(0-360 minutes)
- Amino acids(0-360 minutes)
- Gallbladder emptying(0-360 minutes)
- Fatty acid amide hydrolase genotype(Baseline)
- G-protein coupled receptor 119 genotype(Baseline)
- Triglyceride(0-360 minutes)
研究者
Asger Lund, MD
Associate Professor, MD, PhD
University Hospital, Gentofte, Copenhagen
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