NCT01633762已完成早期 1 期
Eradication of Gut Microbiota - Effects on Postprandial Gut Hormone Secretion, Glucose Metabolism, Bone Metabolism and Gut Microbiome
University Hospital, Gentofte, Copenhagen1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- changes in postprandial GLP-1 secretion
研究概览
简要总结
The aim of the study is to assess the effect of eradication of gut microbiota on 1) glucose metabolism including postprandial plasma responses of the incretin hormones GIP and GLP-1, insulin, C-peptide and glucagon, 2) metabolomic profiles and resting energy expenditure (REE) 3) appetite, satiety, food intake, gastric emptying and gall bladder emptying, 4) levels of markers of bone formation and resorption as well as serotonin, 5) markers of systemic inflammation, and 6) on the (prospective) composition of bacteria in faeces, blood and saliva. Thus, the overall objective is to provide detailed knowledge on the physiological role of gut microbiota combined with bioinformatic analyses of the functional implications of changes in bacteria composition on the level of both species and phylum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •danish caucasian ethnicity
- •informed consent
- •normal fasting plasma glucose
- •normal HbA1c (<6 %)
- •normal serum lipids
- •normal thyroid function
- •normal danish diet
- •non-smoking
- •normal stool habits
排除标准
- •known bone disease
- •liver disease (ALAT or ASAT >2 upper normal value)
- •kidney disease (serum creatinine >130 μM)
- •BMI <18.5 kg/m2 or BMI >25 kg/m2
- •known gastrointestinal disease (including prior bariatric surgery,lactose -intolerance, celiac disease, inflammatory bowel disease) or known familial disposition for lactose intolerance, celiac disease, inflammatory bowel disease
- •antibiotic treatment within 6 months prior to study including malaria prophylaxis
- •medication which cannot be on hold for the study period
- •contraindications against/allergy towards the used antibiotics (including prior allergic reactions related to beta-lactam antibiotics, aminoglycosides or vancomycin)
研究组 & 干预措施
meropenem, gentamicin, vancomycin
Experimental
干预措施: meropenem, gentamicin, vancomycin (together) (Drug)
结局指标
主要结局
changes in postprandial GLP-1 secretion
时间窗: 0, 4 and 42 days after antibiotic eradication of gut bacteria
plasma level of GLP-1 at baseline and during a 4 hour-meal test
次要结局
- changes in glycated hemoglobin (HbA1c)(42 days after antibiotic eradication of gut bacteria)
- changes in postprandial insulin/c-peptide secretion(0, 4 and 42 days after antibiotic eradication of gut bacteria)
- changes in postprandial GLP-2, glucagon, PYY, oxyntomodulin, gastrin, CCK, GIP, leptin, adiponectin and ghrelin secretion(0, 4 and 42 days after antibiotic eradication of gut bacteria)
- changes in basal metabolic rate and respiratory quotient(0, 4 and 42 days after antibiotic eradication of gut bacteria)
- gut microbiome composition(0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria)
- changes in gastric emptying(0, 4 and 42 days after antibiotic eradication of gut bacteria)
- changes in postprandial glucose levels(0, 4 and 42 days after antibiotic eradication of gut bacteria)
- changes in markers of systemic inflammation(0, 4, 42 and 180 days after antibiotic eradication of gut bacteria)
- changes in body weight(0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria)
- appetite, satiety and food intake(0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria)
- changes in markers of bone formation and resorption(0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria)
- changes in gall bladder emptying(0, 4 and 42 days after antibiotic eradication of gut bacteria)
- changes in ketone metabolism(0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria)
- changes in plasma lipid levels(0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria)
- adverse effects of the used antibiotics(up to 180 days after antibiotic eradication of gut bacteria)
- microbiome in blood, urine and saliva(0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria)
- changes in bile acid deconjugation(0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria)
- changes in metabolomic profile(0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria)
研究者
Kristian Hallundbuk Mikkelsen
MD
University Hospital, Gentofte, Copenhagen
研究点 (1)
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