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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

NCT03942432 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2020-12-17

No results posted yet for this study

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

Conditions

  • Dysmetabolic Iron Overload Syndrome

Interventions

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

Sponsors & Collaborators

  • Rennes University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-11
Primary Completion
2020-12-04
Completion
2020-12-04

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03942432 on ClinicalTrials.gov