Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT01572818
Status:
COMPLETED
Last Update Posted:
2016-06-15
First Post:
2011-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Phlebotomy on Insulin Sensitivity in Insulin Resistance-associated Hepatic Iron Overload Patients
Sponsor:
Rennes University Hospital
Organization:
Study Overview
Official Title:
Effects of Phlebotomy on Insulin Sensitivity in Insulin Resistance-associated Hepatic Iron Overload Patients
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAINPOS
Brief Summary:
The purpose of this study is to evaluate efficacy of phlebotomy on insulin sensitivity as evaluated by euglycemic-hyperinsulinic clamp in insulin resistance-associated hepatic iron overload patients.
Detailed Description:
The main objective of this study is to evaluate in patients with HSD effects of treatment with phlebotomy rules with lifestyle and dietary rules versus lifestyle modifications alone on peripheral insulin resistance (assessed by hyperinsulinemic clamp).
Secondary objectives are:
* to study in all patients with HSD the relationship between the amount of iron intrahepatic and degree of peripheral insulin resistance and liver before therapeutic intervention.
* to study and compare the effects of phlebotomy treatment versus no treatment on:
* Plasma levels of adipocytokines,
* Plasma concentrations of inflammatory markers and markers of insulin resistance,
* The serum ferritin,
* The post-hepatic clearance of insulin,
* The surface of the abdominal visceral fat and subcutaneous abdominal.
Secondary objectives are:
* to study in all patients with HSD the relationship between the amount of iron intrahepatic and degree of peripheral insulin resistance and liver before therapeutic intervention.
* to study and compare the effects of phlebotomy treatment versus no treatment on:
* Plasma levels of adipocytokines,
* Plasma concentrations of inflammatory markers and markers of insulin resistance,
* The serum ferritin,
* The post-hepatic clearance of insulin,
* The surface of the abdominal visceral fat and subcutaneous abdominal.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: