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Completed

NCT Number: NCT03942432

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Rennes

Rennes, 35033, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral glucose tolerance test (OGTT)

Other

Blood samples at T0, T30min, T120min

Clinical exam

Other

weight, length, waist measurement, cardiac frequency, blood pressure

Blood sample

Biological

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

MRI

Device

3 Tesla abdominal MRI

Bioimpedance

Device

Measurement of body composition

Questionnaires

Behavioral

Quality of life, physical activity, alcohol consumption and eating habits

Primary outcomes

  1. Dosage of fasting blood glycemia after 5 years

    Time frame: Year 5

    Oral Glucose Tolerance Test (OGTT)

Secondary outcomes

  1. Dosage of iron hepatic concentration proved by MRI after 5 years

    Time frame: Year 5

    Abdominal MRI

  2. Dosage of iron hepatic concentration after 5 years

    Time frame: Year 5

    Blood sample

  3. Dosage of insulin after 5 years

    Time frame: Year 5

    Blood sample

  4. Measurement of body composition

    Time frame: Year 5

    Bioimpedance

  5. Measurement of insulin resistance markers

    Time frame: Year 5

    Oral Glucose Tolerance Test (OGTT)

  6. Measurement of hepatic steatosis after 5 years

    Time frame: Year 5

    Abdominal MRI

  7. Evaluation of cardiovascular morbi-mortality after 5 years

    Time frame: Year 5

    Mixed score based on the following events: angina pectoris, cardiac arrest, stoke

  8. Calculation of Framingham score

    Time frame: Year 5

    Appreciation of cardiovascular event after 10 years based on blood pressure, cholesterol level and HDL, smoking or not, age and gender

  9. Evaluation of quality of life after 5 years

    Time frame: Year 5

    SF-36 questionnaire

  10. Evaluation of physical activity after 5 years

    Time frame: Year 5

    Baecke physical activity questionnaire : scores for physical exercise in leisure, leisure and locomotion activities

  11. Evaluation of eating habits after 5 years

    Time frame: Year 5

    Eating habits questionnaire

  12. Evaluation of alcohol consumption after 5 years

    Time frame: Year 5

    Alcohol consumption questionnaire : number of units of alcohol consumed per day

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: EvoHSD

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 8, 2019
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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