Dysmetabolic Iron Overload SyndromeEvoHSDNCT03942432
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 study testing Oral Glucose Tolerance Test (OGTT), Clinical exam and Blood sample in people with Dysmetabolic Iron Overload Syndrome, run by Rennes University Hospital at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysmetabolic Iron Overload Syndrome
- What is being tested?
- Oral Glucose Tolerance Test (OGTT), Clinical exam and Blood sample
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jun 2019to 4 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Dysmetabolic Iron Overload Syndrome
- Being tested
- Oral Glucose Tolerance Test (OGTT), Clinical exam, Blood sample, MRI, Bioimpedance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Glucose Tolerance Test (OGTT)Other
Blood samples at T0, T30min, T120min
Clinical examOther
weight, length, waist measurement, cardiac frequency, blood pressure
Blood sampleBiological
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
MRIDevice
3 Tesla abdominal MRI
BioimpedanceDevice
Measurement of body composition
QuestionnairesBehavioural
Quality of life, physical activity, alcohol consumption and eating habits
| Study group | Role | What they receive |
|---|---|---|
| Patients with dysmetabolic iron overload syndrome | Experimental | Not described Receives: Other: Oral Glucose Tolerance Test (OGTT); Other: Clinical exam; Biological: Blood sample; Device: MRI; Device: Bioimpedance; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosage of fasting blood glycemia after 5 years
Oral Glucose Tolerance Test (OGTT)
Measured: Year 5
Secondary outcomes (12)
Dosage of iron hepatic concentration proved by MRI after 5 years
Abdominal MRI
Measured: Year 5
Dosage of iron hepatic concentration after 5 years
Blood sample
Measured: Year 5
Dosage of insulin after 5 years
Blood sample
Measured: Year 5
Measurement of body composition
Bioimpedance
Measured: Year 5
Measurement of insulin resistance markers
Oral Glucose Tolerance Test (OGTT)
Measured: Year 5
Measurement of hepatic steatosis after 5 years
Abdominal MRI
Measured: Year 5
Evaluation of cardiovascular morbi-mortality after 5 years
Mixed score based on the following events: angina pectoris, cardiac arrest, stoke
Measured: 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
Measured: Year 5
Evaluation of quality of life after 5 years
SF-36 questionnaire
Measured: Year 5
Evaluation of physical activity after 5 years
Baecke physical activity questionnaire : scores for physical exercise in leisure, leisure and locomotion activities
Measured: Year 5
Evaluation of eating habits after 5 years
Eating habits questionnaire
Measured: Year 5
Evaluation of alcohol consumption after 5 years
Alcohol consumption questionnaire : number of units of alcohol consumed per day
Measured: Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start11 Jun 2019
- Primary completion4 Dec 2020
- Study completion4 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysmetabolic Iron Overload SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942432
- Sponsor's protocol ID
- 35RC18_8847_EvoHSD
- Acronym
- EvoHSD
- Status last verified
- Dec 2020
- First submitted
- 26 Apr 2019
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03942432
- Acronym / sponsor ID
- EvoHSD / 35RC18_8847_EvoHSD
- Conditions
- Dysmetabolic Iron Overload Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 4 Dec 2020 (actual)
- Study completion
- 4 Dec 2020 (actual)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with dysmetabolic iron overload syndrome | Experimental | Other: Oral Glucose Tolerance Test (OGTT), Other: Clinical exam, Biological: Blood sample, Device: MRI, Device: Bioimpedance, Behavioral: Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Glucose Tolerance Test (OGTT)Blood samples at T0, T30min, T120min | Other | Patients with dysmetabolic iron overload syndrome |
| Clinical examweight, length, waist measurement, cardiac frequency, blood pressure | Other | Patients with dysmetabolic iron overload syndrome |
| Blood sampleIron 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 | Biological | Patients with dysmetabolic iron overload syndrome |
| MRI3 Tesla abdominal MRI | Device | Patients with dysmetabolic iron overload syndrome |
| BioimpedanceMeasurement of body composition | Device | Patients with dysmetabolic iron overload syndrome |
| QuestionnairesQuality of life, physical activity, alcohol consumption and eating habits | Behavioural | Patients with dysmetabolic iron overload syndrome |
Primary outcome
Dosage of fasting blood glycemia after 5 years
Time frame: Year 5
Oral Glucose Tolerance Test (OGTT)
12 secondary outcomes
Dosage of iron hepatic concentration proved by MRI after 5 years
Time frame: Year 5
Dosage of iron hepatic concentration after 5 years
Time frame: Year 5
Dosage of insulin after 5 years
Time frame: Year 5
Measurement of body composition
Time frame: Year 5
Measurement of insulin resistance markers
Time frame: Year 5
Measurement of hepatic steatosis after 5 years
Time frame: Year 5
Evaluation of cardiovascular morbi-mortality after 5 years
Time frame: Year 5
Calculation of Framingham score
Time frame: Year 5
Evaluation of quality of life after 5 years
Time frame: Year 5
Evaluation of physical activity after 5 years
Time frame: Year 5
Evaluation of eating habits after 5 years
Time frame: Year 5
Evaluation of alcohol consumption after 5 years
Time frame: Year 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Glucose Tolerance Test (OGTT), Clinical exam and Blood sample in people with Dysmetabolic Iron Overload Syndrome, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosage of fasting blood glycemia after 5 years (time frame: Year 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.