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

Not Applicable

Completed

• Conditions: Dysmetabolic Iron Overload Syndrome
• Interventions: Other: Oral Glucose Tolerance Test (OGTT); Other: Clinical exam; Biological: Blood sample; Device: MRI; Device: Bioimpedance; Behavioral: Questionnaires

• Registration Number: NCT03942432
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study First Submitted: 2019-04-26
• Study First Submitted QC: 2019-05-06
• Study First Posted: 2019-05-08
• Study Start: 2019-06-11
• Status Verified: 2020-12
• Primary Completion: 2020-12-04
• Study Completion: 2020-12-04
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with dysmetabolic iron overload syndrome	Clinical exam	-
Patients with dysmetabolic iron overload syndrome	MRI	-
Patients with dysmetabolic iron overload syndrome	Bioimpedance	-
Patients with dysmetabolic iron overload syndrome	Questionnaires	-
Patients with dysmetabolic iron overload syndrome	Oral Glucose Tolerance Test (OGTT)	-
Patients with dysmetabolic iron overload syndrome	Blood sample	-

Primary Outcome Measures

Name	Time	Method
Dosage of fasting blood glycemia after 5 years	Year 5	Oral Glucose Tolerance Test (OGTT)

Secondary Outcome Measures

Name	Time	Method
Dosage of iron hepatic concentration after 5 years	Year 5	Blood sample
Dosage of insulin after 5 years	Year 5	Blood sample
Evaluation of quality of life after 5 years	Year 5	SF-36 questionnaire
Evaluation of eating habits after 5 years	Year 5	Eating habits questionnaire
Evaluation of alcohol consumption after 5 years	Year 5	Alcohol consumption questionnaire : number of units of alcohol consumed per day
Measurement of insulin resistance markers	Year 5	Oral Glucose Tolerance Test (OGTT)
Dosage of iron hepatic concentration proved by MRI after 5 years	Year 5	Abdominal MRI
Evaluation of cardiovascular morbi-mortality after 5 years	Year 5	Mixed score based on the following events: angina pectoris, cardiac arrest, stoke
Calculation of Framingham score	Year 5	Appreciation of cardiovascular event after 10 years based on blood pressure, cholesterol level and HDL, smoking or not, age and gender
Evaluation of physical activity after 5 years	Year 5	Baecke physical activity questionnaire : scores for physical exercise in leisure, leisure and locomotion activities
Measurement of body composition	Year 5	Bioimpedance
Measurement of hepatic steatosis after 5 years	Year 5	Abdominal MRI

Trial Locations

Locations (1)

CHU Rennes; 🇫🇷 Rennes, France