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)
Primary Purpose
Dysmetabolic Iron Overload Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Oral Glucose Tolerance Test (OGTT)
Clinical exam
Blood sample
MRI
Bioimpedance
Questionnaires
Sponsored by
About this trial
This is an interventional other trial for Dysmetabolic Iron Overload Syndrome
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
Sites / Locations
- CHU Rennes
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with dysmetabolic iron overload syndrome
Arm Description
Outcomes
Primary Outcome Measures
Dosage of fasting blood glycemia after 5 years
Oral Glucose Tolerance Test (OGTT)
Secondary Outcome Measures
Dosage of iron hepatic concentration proved by MRI after 5 years
Abdominal MRI
Dosage of iron hepatic concentration after 5 years
Blood sample
Dosage of insulin after 5 years
Blood sample
Measurement of body composition
Bioimpedance
Measurement of insulin resistance markers
Oral Glucose Tolerance Test (OGTT)
Measurement of hepatic steatosis after 5 years
Abdominal MRI
Evaluation of cardiovascular morbi-mortality after 5 years
Mixed score based on the following events: angina pectoris, cardiac arrest, stoke
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
Evaluation of quality of life after 5 years
SF-36 questionnaire
Evaluation of physical activity after 5 years
Baecke physical activity questionnaire : scores for physical exercise in leisure, leisure and locomotion activities
Evaluation of eating habits after 5 years
Eating habits questionnaire
Evaluation of alcohol consumption after 5 years
Alcohol consumption questionnaire : number of units of alcohol consumed per day
Full Information
NCT ID
NCT03942432
First Posted
April 26, 2019
Last Updated
December 16, 2020
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03942432
Brief 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
Acronym
EvoHSD
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
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 11, 2019 (Actual)
Primary Completion Date
December 4, 2020 (Actual)
Study Completion Date
December 4, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmetabolic Iron Overload Syndrome
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with dysmetabolic iron overload syndrome
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Oral Glucose Tolerance Test (OGTT)
Intervention Description
Blood samples at T0, T30min, T120min
Intervention Type
Other
Intervention Name(s)
Clinical exam
Intervention Description
weight, length, waist measurement, cardiac frequency, blood pressure
Intervention Type
Biological
Intervention Name(s)
Blood sample
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
3 Tesla abdominal MRI
Intervention Type
Device
Intervention Name(s)
Bioimpedance
Intervention Description
Measurement of body composition
Intervention Type
Behavioral
Intervention Name(s)
Questionnaires
Intervention Description
Quality of life, physical activity, alcohol consumption and eating habits
Primary Outcome Measure Information:
Title
Dosage of fasting blood glycemia after 5 years
Description
Oral Glucose Tolerance Test (OGTT)
Time Frame
Year 5
Secondary Outcome Measure Information:
Title
Dosage of iron hepatic concentration proved by MRI after 5 years
Description
Abdominal MRI
Time Frame
Year 5
Title
Dosage of iron hepatic concentration after 5 years
Description
Blood sample
Time Frame
Year 5
Title
Dosage of insulin after 5 years
Description
Blood sample
Time Frame
Year 5
Title
Measurement of body composition
Description
Bioimpedance
Time Frame
Year 5
Title
Measurement of insulin resistance markers
Description
Oral Glucose Tolerance Test (OGTT)
Time Frame
Year 5
Title
Measurement of hepatic steatosis after 5 years
Description
Abdominal MRI
Time Frame
Year 5
Title
Evaluation of cardiovascular morbi-mortality after 5 years
Description
Mixed score based on the following events: angina pectoris, cardiac arrest, stoke
Time Frame
Year 5
Title
Calculation of Framingham score
Description
Appreciation of cardiovascular event after 10 years based on blood pressure, cholesterol level and HDL, smoking or not, age and gender
Time Frame
Year 5
Title
Evaluation of quality of life after 5 years
Description
SF-36 questionnaire
Time Frame
Year 5
Title
Evaluation of physical activity after 5 years
Description
Baecke physical activity questionnaire : scores for physical exercise in leisure, leisure and locomotion activities
Time Frame
Year 5
Title
Evaluation of eating habits after 5 years
Description
Eating habits questionnaire
Time Frame
Year 5
Title
Evaluation of alcohol consumption after 5 years
Description
Alcohol consumption questionnaire : number of units of alcohol consumed per day
Time Frame
Year 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CHU Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
12. IPD Sharing Statement
Learn more about this trial
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
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