Clinical trial NCT03942432: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysmetabolic Iron Overload Syndrome
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Dosage of fasting blood glycemia after 5 years
timeFrame: Year 5
Secondary outcomes:
measure: Dosage of iron hepatic concentration proved by MRI after 5 years
timeFrame: Year 5
measure: Dosage of iron hepatic concentration after 5 years
timeFrame: Year 5
measure: Dosage of insulin after 5 years
timeFrame: Year 5
measure: Measurement of body composition
timeFrame: Year 5
measure: Measurement of insulin resistance markers
timeFrame: Year 5
measure: Measurement of hepatic steatosis after 5 years
timeFrame: Year 5
measure: Evaluation of cardiovascular morbi-mortality after 5 years
timeFrame: Year 5
measure: Calculation of Framingham score
timeFrame: Year 5
measure: Evaluation of quality of life after 5 years
timeFrame: Year 5
measure: Evaluation of physical activity after 5 years
timeFrame: Year 5
measure: Evaluation of eating habits after 5 years
timeFrame: Year 5
measure: Evaluation of alcohol consumption after 5 years
timeFrame: Year 5
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
Study officials:
References: