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 | Completed

• 1 other identifier: 35RC18_8847_EvoHSD
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

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

Study Arms (1)

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

Interventions

Oral Glucose Tolerance Test (OGTT) OTHER

Blood samples at T0, T30min, T120min

Patients with dysmetabolic iron overload syndrome

Clinical exam OTHER

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

Patients with dysmetabolic iron overload syndrome

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

Patients with dysmetabolic iron overload syndrome

MRI DEVICE

3 Tesla abdominal MRI

Patients with dysmetabolic iron overload syndrome

Bioimpedance DEVICE

Measurement of body composition

Patients with dysmetabolic iron overload syndrome

Questionnaires BEHAVIORAL

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

Patients with dysmetabolic iron overload syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU Rennes

Rennes, 35033, France

Location

MeSH Terms

Interventions

Glucose Tolerance Test; Blood Specimen Collection; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques; Specimen Handling; Punctures; Surgical Procedures, Operative; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment 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)