Diabetes Mellitus Clinical Trial
Official title:
Iron Depletion Therapy for Patients With Type 2 Diabetes Mellitus and Non-Alcoholic Fatty Liver Disease
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 and/or a decrease in the amount of liver fat.
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 person's 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 P&F 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 and/or 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.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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