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出境医 / 临床实验 / 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 (EvoHSD)
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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dysmetabolic Iron Overload Syndrome | Other: Oral Glucose Tolerance Test (OGTT) Other: Clinical exam Biological: Blood sample Device: MRI Device: Bioimpedance Behavioral: Questionnaires | Not Applicable |
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 Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 75 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| 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 |
| Actual Study Start Date : | June 11, 2019 |
| Actual Primary Completion Date : | December 4, 2020 |
| Actual Study Completion Date : | December 4, 2020 |
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures :
- Dosage of fasting blood glycemia after 5 years [ Time Frame: Year 5 ]Oral Glucose Tolerance Test (OGTT)
Secondary Outcome Measures :
- Dosage of iron hepatic concentration proved by MRI after 5 years [ Time Frame: Year 5 ]Abdominal MRI
- Dosage of iron hepatic concentration after 5 years [ Time Frame: Year 5 ]Blood sample
- Dosage of insulin after 5 years [ Time Frame: Year 5 ]Blood sample
- Measurement of body composition [ Time Frame: Year 5 ]Bioimpedance
- Measurement of insulin resistance markers [ Time Frame: Year 5 ]Oral Glucose Tolerance Test (OGTT)
- Measurement of hepatic steatosis after 5 years [ Time Frame: Year 5 ]Abdominal MRI
- Evaluation of cardiovascular morbi-mortality after 5 years [ Time Frame: Year 5 ]Mixed score based on the following events: angina pectoris, cardiac arrest, stoke
- 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
- Evaluation of quality of life after 5 years [ Time Frame: Year 5 ]SF-36 questionnaire
- 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
- Evaluation of eating habits after 5 years [ Time Frame: Year 5 ]Eating habits questionnaire
- Evaluation of alcohol consumption after 5 years [ Time Frame: Year 5 ]Alcohol consumption questionnaire : number of units of alcohol consumed per day
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Locations
| France | |
| CHU Rennes | |
| Rennes, France, 35033 | |
Sponsors and Collaborators
Rennes University Hospital
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 26, 2019 | ||||
| First Posted Date ICMJE | May 8, 2019 | ||||
| Last Update Posted Date | December 17, 2020 | ||||
| Actual Study Start Date ICMJE | June 11, 2019 | ||||
| Actual Primary Completion Date | December 4, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Dosage of fasting blood glycemia after 5 years [ Time Frame: Year 5 ] Oral Glucose Tolerance Test (OGTT)
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | 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 | ||||
| Official Title ICMJE | 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 | ||||
| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other |
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| Condition ICMJE | Dysmetabolic Iron Overload Syndrome | ||||
| Intervention ICMJE |
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| Study Arms ICMJE | Experimental: Patients with dysmetabolic iron overload syndrome
Interventions:
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
75 | ||||
| Original Estimated Enrollment ICMJE |
152 | ||||
| Actual Study Completion Date ICMJE | December 4, 2020 | ||||
| Actual Primary Completion Date | December 4, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03942432 | ||||
| Other Study ID Numbers ICMJE | 35RC18_8847_EvoHSD | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Rennes University Hospital | ||||
| Study Sponsor ICMJE | Rennes University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Rennes University Hospital | ||||
| Verification Date | December 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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