ISRCTN81954082已完成不适用
Role of gastrointestinal hormones and bile acids on microbiota in bariatric surgery with different degrees of malabsorption
Fondo de Investigaciones Sanitarias - Instituto de Salud Carlos III-FEDER (PI-16/01655)0 个研究点目标入组 96 人开始时间: 2018年2月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Patients on the bariatric surgery waiting list
- •2. Caucasian men and women aged 18-65
- •3. BMI = 40 kg/m2 or = 35 kg/m2 with at least one major comorbidities (Type 2 diabetes, hypertension, hyperlipemia, sleep obstructive apnea)
- •4. Absence of serious disease (chronic kidney disease, liver disease, neurological disease)
- •5. Absence of psychiatric pathology
- •6. Ability to understand the mechanisms involved in the surgery that will be proposed
- •7. Written informed consent to participate in the study
- •Inclusion criteria for the control group:
- •1. Caucasian men and women, aged 18-65 years (matched with patients)
- •2. BMI 20-29.9 kg/m2
- •3. No pregnant and lactating women
- •4. Absence of major comorbidities (Type 2 diabetes, hypertension, hyperlipidemia, sleep obstructive apnea)
- •5. Absence of serious diseases (chronic kidney or liver disease, inflammatory diseases, neurological diseases, cancer, AIDS)
- •6. Absence of psychiatric disorders
- •7. Written informed consent to participate in the study
排除标准
- •1. Systemic disease not associated with obesity (inflammatory bowel disease, inflammatory rheumatic disease)
- •2. Hepatitis C, known cirrhosis (or discovered during the study)
- •4. Drug and/or alcohol abuse
- •5. Eating disorders
研究者
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Changes in stool habits and in the balance and regulation of bile acids after surgical removal of the gall bladderPost cholecystectomy bile acid diarrhoea/malabsorptionMedDRA version: 19.1Level: PTClassification code 10069703Term: Bile acid malabsorptionSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 19.1Level: PTClassification code 10008611Term: CholecystectomySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 19.1Level: LLTClassification code 10066557Term: Chronic diarrhoeaSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 19.1Level: PTClassification code 10057229Term: Post cholecystectomy syndromeSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2016-004692-53-DKZealand University Hospital Køge20
