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 (EvoHSD)

Rennes University Hospital

Status: Completed

Conditions: Dysmetabolic Iron Overload Syndrome

Treatments: Device: Bioimpedance; Behavioral: Questionnaires; Biological: Blood sample; Other: Clinical exam; Device: MRI; Other: Oral Glucose Tolerance Test (OGTT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03942432

35RC18_8847_EvoHSD

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Patients with dysmetabolic iron overload syndrome

Experimental group

Treatment:

Device: MRI

Biological: Blood sample

Other: Oral Glucose Tolerance Test (OGTT)

Device: Bioimpedance

Other: Clinical exam

Behavioral: Questionnaires