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临床试验/NL-OMON56270
NL-OMON56270招募中不适用

Preoperative predictors of weight loss and improved metabolic health after bariatric surgery - Predictors of weight loss and metabolic health after bariatric surgery

Endocrinologie&metabolisme0 个研究点目标入组 1,200 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,200

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

年龄范围
18 至 99(—)

入选标准

  • * Ability to provide informed consent
  • * Patient is >= 18 and <= 75 years old
  • * BMI >= 40 kg/m2 or >= 35 kg/m2 with obesity related comorbidity
  • * Scheduled for primary bariatric procedure: Roux-en-Y gastric bypass (RYGB) or
  • Sleeve Gastrectomy (SG)
  • * Stable weight 3 months prior to inclusion weight (<10% change in body weight
  • for 3 months prior to assessments)
  • In order to be eligible to participate in the subgroup of this study, we will
  • use the following inclusion criteria:
  • * We will include only patients who will undergo RYGB;
  • * Patients who are insulin resistant (impaired fasting glucose (> 5.6 mmol/L)
  • or fasting insulin > 74 pmol/L)
  • * Postmenopausal women (to prevent bias due to the effect of sex homones on
  • insulin sensitivity)

排除标准

  • A potential subject who meets any of the following criteria will be excluded
  • from participation in this study:
  • * Patients who do not understand the patient information letter
  • * Any actual medical condition except for obesity related health issues or well
  • treated hypothyroidism
  • * Pregnancy anticipated in the first two years following surgery
  • A potential subject who meet the following criteria will be excluded from
  • participation in the subgroup of this study:
  • * Coagulation disorders and/or use anticoagulants
  • * Use of any medication except for statins, antihypertensives (except for ACE-
  • or angiotensin receptor blockers) and thyroid hormone
  • * Diabetes mellitus type 2

研究者

发起方
Endocrinologie&metabolisme

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