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

Dysmetabolic Iron Overload Syndrome Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03942432
• Other study ID #: 35RC18_8847_EvoHSD
• Status: Completed
• Phase: N/A
• Start date: June 11, 2019
• Est. completion date: December 4, 2020

Study information

• Verified date: December 2020
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 4, 2020
• Est. primary completion date: December 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dysmetabolic Iron Overload Syndrome
• Iron Overload
• Syndrome

Intervention

Other:
• Oral Glucose Tolerance Test (OGTT)
Blood samples at T0, T30min, T120min
• 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
• Bioimpedance
Measurement of body composition

Behavioral:
• Questionnaires
Quality of life, physical activity, alcohol consumption and eating habits

Locations

Country	Name	City	State
France	CHU Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosage of fasting blood glycemia after 5 years	Oral Glucose Tolerance Test (OGTT)	Year 5
Secondary	Dosage of iron hepatic concentration proved by MRI after 5 years	Abdominal MRI	Year 5
Secondary	Dosage of iron hepatic concentration after 5 years	Blood sample	Year 5
Secondary	Dosage of insulin after 5 years	Blood sample	Year 5
Secondary	Measurement of body composition	Bioimpedance	Year 5
Secondary	Measurement of insulin resistance markers	Oral Glucose Tolerance Test (OGTT)	Year 5
Secondary	Measurement of hepatic steatosis after 5 years	Abdominal MRI	Year 5
Secondary	Evaluation of cardiovascular morbi-mortality after 5 years	Mixed score based on the following events: angina pectoris, cardiac arrest, stoke	Year 5
Secondary	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
Secondary	Evaluation of quality of life after 5 years	SF-36 questionnaire	Year 5
Secondary	Evaluation of physical activity after 5 years	Baecke physical activity questionnaire : scores for physical exercise in leisure, leisure and locomotion activities	Year 5
Secondary	Evaluation of eating habits after 5 years	Eating habits questionnaire	Year 5
Secondary	Evaluation of alcohol consumption after 5 years	Alcohol consumption questionnaire : number of units of alcohol consumed per day	Year 5