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临床试验/NCT03942432
NCT03942432已完成不适用

A Prospective, Mono-center, Interventional Study Evaluating the Effect of One Year Initial Care by Hygieno-dietary Advices With or Without Phlebotomy on Glycemia After at Least 5 Years in Patients With Dysmetabolic Iron Overload Syndrome

Rennes University Hospital2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2019年6月11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
75
试验地点
2
主要终点
Dosage of fasting blood glycemia after 5 years

研究概览

简要总结

A prospective, mono-center, interventional study evaluating the effect of one year initial care by hygieno-dietary advices with or without Phlebotomy on glycemia after at least 5 years in Patients with dysmetabolic iron overload syndrome

详细描述

Dysmetabolic iron overload syndrome (DIOS) is defined by a slight iron overload associated to features of the metabolic syndrome. This is a frequent condition that parallels the increasing prevalence of non alcoholic steato hepatitis. The role of iron overload on insulin sensitivity is described in large cohorts study, with an increased risk of type 2 diabetes in patients with increased serum ferritin, and in vitro where iron load alters key regulators of lipid and glucose metabolism.

In patient with DIOS, improving diet and lifestyle is a major goal, albeit it does not allow to lower body iron stores. Therefore the role of bloodletting in this setting was raised. Several low quality studies suggested a beneficial effect of bloodletting on insulin resistance. Our group demonstrated in a large multicenter randomized trial, the lack of beneficial effect of bloodletting over one year. Because this may be a too short period of time to demonstrate a positive effect we would like to assess the long term effect of iron depletion on insulin resistance and its clinical consequence.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Persons who participated in the " Phlebotomy " protocol: A Prospective, Randomized Study Comparing Effect of Phlebotomy and Hygieno-dietary Advices With Hygieno-dietary Advices Only on Glycemia in Patients With Dysmetabolic Iron Overload Syndrome
  • Persons affiliated to French Social Security
  • Persons who received an oral and written information on the protocol and signed the informed consent form

排除标准

  • Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship) since their enrolment in the "Phlebotomy" protocol
  • Persons deprived of liberty
  • Pregnant or breastfeeding women

结局指标

主要结局

Dosage of fasting blood glycemia after 5 years

时间窗: Year 5

Oral Glucose Tolerance Test (OGTT)

次要结局

  • Dosage of iron hepatic concentration after 5 years(Year 5)
  • Dosage of insulin after 5 years(Year 5)
  • Evaluation of quality of life after 5 years(Year 5)
  • Evaluation of eating habits after 5 years(Year 5)
  • Evaluation of alcohol consumption after 5 years(Year 5)
  • Measurement of insulin resistance markers(Year 5)
  • Dosage of iron hepatic concentration proved by MRI after 5 years(Year 5)
  • Evaluation of cardiovascular morbi-mortality after 5 years(Year 5)
  • Calculation of Framingham score(Year 5)
  • Evaluation of physical activity after 5 years(Year 5)
  • Measurement of body composition(Year 5)
  • Measurement of hepatic steatosis after 5 years(Year 5)

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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