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)

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 Overview

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

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 Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35033
    • CHU Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Patients with dysmetabolic iron overload syndrome

Other: Oral Glucose Tolerance Test (OGTT); Blood samples at T0, T30min, T120min; Other: Clinical exam; weight, length, waist measurement, cardiac frequency, blood pressure; Biological: Blood sample; Iron and cardiac markers Serum iron, serum transferrin, transferrin saturation, serum ferritin, AST, ALT, GGT, ALP, PT, Cell Blood Count, ceruloplasminemia , hyaluronic acid, cholesterolemia, HDL, LDL, triglyceridemia, hba1c; Device: MRI; 3 Tesla abdominal MRI; Device: Bioimpedance; Measurement of body composition; Behavioral: Questionnaires; Quality of life, physical activity, alcohol consumption and eating habits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosage of fasting blood glycemia after 5 years	Oral Glucose Tolerance Test (OGTT)	Year 5

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 11, 2019
• Primary Completion (ACTUAL): December 4, 2020
• Study Completion (ACTUAL): December 4, 2020

Study Registration Dates

• First Submitted: April 26, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (ACTUAL): May 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Disease; Iron Metabolism Disorders; Syndrome; Iron Overload
• Other Study ID Numbers: 35RC18_8847_EvoHSD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No