NCT03942432

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dysmetabolic Iron Overload Syndrome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-06-11
• Primary completion: 2020-12-04
• Completion: 2020-12-04
• First posted: 2019-05-08
• Last updated: 2020-12-17

Locations

1 site across 1 country: France