NCT03942432

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

June 11, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

1.5 years

First QC Date

April 26, 2019

Last Update Submit

December 16, 2020

Conditions

Dysmetabolic Iron Overload Syndrome

Outcome Measures

Primary Outcomes (1)

  • Dosage of fasting blood glycemia after 5 years

    Oral Glucose Tolerance Test (OGTT)

    Year 5

Secondary Outcomes (12)

  • Dosage of iron hepatic concentration proved by MRI after 5 years

    Year 5

  • Dosage of iron hepatic concentration after 5 years

    Year 5

  • Dosage of insulin after 5 years

    Year 5

  • Measurement of body composition

    Year 5

  • Measurement of insulin resistance markers

    Year 5

  • +7 more secondary outcomes

Study Arms (1)

Patients with dysmetabolic iron overload syndrome

EXPERIMENTAL
Other: Oral Glucose Tolerance Test (OGTT)Other: Clinical examBiological: Blood sampleDevice: MRIDevice: BioimpedanceBehavioral: Questionnaires

Interventions

Oral Glucose Tolerance Test (OGTT)OTHER

Blood samples at T0, T30min, T120min

Patients with dysmetabolic iron overload syndrome
Clinical examOTHER

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

Patients with dysmetabolic iron overload syndrome
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

Patients with dysmetabolic iron overload syndrome
MRIDEVICE

3 Tesla abdominal MRI

Patients with dysmetabolic iron overload syndrome
BioimpedanceDEVICE

Measurement of body composition

Patients with dysmetabolic iron overload syndrome
QuestionnairesBEHAVIORAL

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

Patients with dysmetabolic iron overload syndrome

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Rennes

Rennes, 35033, France

Location

MeSH Terms

Interventions

Glucose Tolerance TestBlood Specimen CollectionSurveys and Questionnaires

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative TechniquesSpecimen HandlingPuncturesSurgical Procedures, OperativeData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2019

First Posted

May 8, 2019

Study Start

June 11, 2019

Primary Completion

December 4, 2020

Study Completion

December 4, 2020

Last Updated

December 17, 2020

Record last verified: 2020-12

Locations

FR(1)