Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00230087
Status:
COMPLETED
Last Update Posted:
2012-11-07
First Post:
2005-09-29
Brief Title:
Iron Depletion Therapy for Type 2 DM and NAFLD
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Iron Depletion Therapy for Patients With Type 2 Diabetes Mellitus and Non-Alcoholic Fatty Liver Disease
Status:
COMPLETED
Status Verified Date:
2012-11
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:
None
Brief Summary:
The purpose of this study is to find out whether lowering the amount of iron in the body will result in less resistance to insulin and improved liver function in patients with type 2 diabetes mellitus and non-alcoholic fatty liver disease This may result in better diabetes control andor a decrease in the amount of liver fat
Detailed Description:
Nonalcoholic fatty liver disease NAFLD is a common liver disease in the United States NAFLD can lead to severe liver disease in some patients Patients with NAFLD develop resistance to the normal action of insulin Insulin is important for processing sugar and fat and increased resistance to insulin leads to fat in the liver There is a correlation between the amount of iron in a persons body and the ability of insulin to work properly Several small studies suggest that removal of iron may improve both diabetes and NAFLD by lowering insulin resistance
The goal of this pilot study is to determine the effect of iron depletion on insulin sensitivity in patients with type 2 diabetes mellitus and non-alcoholic fatty liver disease This study will be performed as an ancillary PF study to the NASH CRN all participants will be recruited from the NASH CRN Database Study Secondary outcome measures will include the effect of iron depletion on hepatic necroinflammation markers of oxidative stress and intrahepatic fat content Insulin resistance will be directly measured using a two-step hyperinsulinemic euglycemic clamp procedure before and after iron depletion by phlebotomy Oral glucose tolerance tests will also be performed in order to evaluate the efficacy of using the indirect but less cumbersome HOMA model to derive values of insulin resistance in this patient cohort This study will advance our understanding of the role of body iron stores in the pathophysiology of type 2 diabetes mellitus and non-alcoholic fatty liver disease If iron depletion results in improved insulin sensitivity reduced hepatic necroinflammation andor intrahepatic fat content a large scale randomized controlled trial of iron depletion in patients with type 2 diabetes mellitus and non-alcoholic fatty liver disease will be planned
The goal of this pilot study is to determine the effect of iron depletion on insulin sensitivity in patients with type 2 diabetes mellitus and non-alcoholic fatty liver disease This study will be performed as an ancillary PF study to the NASH CRN all participants will be recruited from the NASH CRN Database Study Secondary outcome measures will include the effect of iron depletion on hepatic necroinflammation markers of oxidative stress and intrahepatic fat content Insulin resistance will be directly measured using a two-step hyperinsulinemic euglycemic clamp procedure before and after iron depletion by phlebotomy Oral glucose tolerance tests will also be performed in order to evaluate the efficacy of using the indirect but less cumbersome HOMA model to derive values of insulin resistance in this patient cohort This study will advance our understanding of the role of body iron stores in the pathophysiology of type 2 diabetes mellitus and non-alcoholic fatty liver disease If iron depletion results in improved insulin sensitivity reduced hepatic necroinflammation andor intrahepatic fat content a large scale randomized controlled trial of iron depletion in patients with type 2 diabetes mellitus and non-alcoholic fatty liver disease will be planned
Study Oversight
Has Oversight DMC:
None
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?:
None