NCT01666223已完成不适用
Effect of Bile Acids in the Gut on GLP-1 Secretion in Healthy Subjects and Patients With Type 2 Diabetes
University Hospital, Gentofte, Copenhagen1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in GLP-1
研究概览
简要总结
The purpose of this study is to describe the physiological, pathophysiological and potentially therapeutic implications of bile-induced glucagon-like peptide-1 (GLP-1) secretion in human glucose homeostasis.
详细描述
The investigators hypothesize that even modest increments in endogenous GLP-1 secretion will elicit important antidiabetic effects of GLP-1. To evaluate whether bile acids have such effects, the investigators plan to perform intraduodenal infusion of two different bile acids and placebo.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •danish caucasian ethnicity
- •normal haemoglobin
- •BMI > 25 kg/m2
- •HbA1c < 9%
- •informed consent
排除标准
- •liver disease(ALT and AST > upper reference limit)
- •gastrointestinal disease
- •liver and biliary tract disease
- •nephropathy (serum creatinine > 150 μM, and/or albuminuria)
- •treatment with insulin, glp-1 analogues and/ or DPP-4 inhibitors
- •treatment with medicine that can not be paused for 12 hours
- •previous abdominal surgery eg. cholecystectomy
- •BMI < 18,5 kg/m2 or > 35 kg/m2
- •Healthy Volunteers
- •Inclusion Criteria:
- •danish caucasian ethnicity
- •normal haemoglobin
- •HbA1c < 6,0 (American Diabetes Association guidelines)
- •informed consent
- •Exclusion Criteria:
- •liver disease(ALT and AST > upper reference limit)
- •gastrointestinal disease
- •liver and biliary tract disease
- •nephropathy (serum creatinine > 150 μM, and/or albuminuria)
- •treatment with medicine that can not be paused for 12 hours
- •previous abdominal surgery eg. cholecystectomy
- •BMI < 18,5 kg/m2 or > 35 kg/m2
- •first degree relatives diagnosed with diabetes
- •previously diagnosed with diabetes, or treated with antidiabetic agents
研究组 & 干预措施
Colesevelam
Experimental
干预措施: Colesevelam (Drug)
Chenodeoxycholic acid
Experimental
干预措施: Chenodeoxycholic Acid (Drug)
Colesevelam + chenodeoxycholic acid
Experimental
干预措施: Colesevelam 3750 mg + chenodeoxycholic acid 1250 mg (Drug)
Placebo
Experimental
干预措施: saline (Other)
结局指标
主要结局
Change in GLP-1
时间窗: At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes
次要结局
- Change in peptide YY (PYY)(At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes)
- Change in oxyntomodulin(At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes)
- Change in bile acids(At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes)
- Change in gastrin(At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes)
- Change in CCK(At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes)
- Change in appetite, satiety and prospective food consumption(At baseline, and 30, 60, 90, 120 and 180 minutes)
- Change in gallbladder volume(-30, 0 (baseline), 30, 60, 120 og 180 minutes)
- Change in basal metabolic rate(At -30, 60 og 150 minutes)
- Change in bile acid composition(At -30, 0, 30, 60, 120 og 180 minutes)
- Change in insulin(At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes)
- Change in C-peptide(At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes)
- Change in glucagon(At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes)
- Change in glucagon-like-peptide 2 (GLP-2)(At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes)
- Change in glucose-dependent insulinotropic polypeptide (GIP)(At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes)
研究者
Morten Hansen
MD, PhD Student
University Hospital, Gentofte, Copenhagen
研究点 (1)
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