跳至主要内容
临床试验/ISRCTN81954082
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

发起方
Fondo de Investigaciones Sanitarias - Instituto de Salud Carlos III-FEDER (PI-16/01655)

相似试验

已完成
不适用
Changes in gastrointestinal hormones after bariatric surgeryMorbid obesityNutritional, Metabolic, Endocrine
ISRCTN12131308San Carlos Clinical Hospital (Hospital Clínico San Carlos)70
已完成
不适用
Gastrointestinal hormones and genes associated to type 2 diabetes remission in non-morbid obesity after bariatric surgeryType 2 diabetesNutritional, Metabolic, EndocrineNon-insulin-dependent diabetes mellitus
ISRCTN57114193Fundación Mutua Madrileña (Spain)60
尚未招募
不适用
The physiological role of bile acid‐mediated glucagon‐like peptide‐1 release in humans: The Cerebrotendinous Xanthomatosis Mixed Meal Test study.
NL-OMON23193AMC28
招募中
不适用
The effects of probiotics on glycaemic control in Type 2 diabetes mellitus patientsType 2 Diabetes Mellitus
ACTRN12615001135505Dr. Neoh Chin Fen100
进行中(未招募)
1 期
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 disorders
EUCTR2016-004692-53-DKZealand University Hospital Køge20