Iron Depletion Therapy for Type 2 DM and NAFLD

ironjustice@aol.com · medicine forum Guru Joined: 28 Apr 2005 Posts: 1522

http://www.clinicaltrials.gov/show/NCT00230087

Iron Depletion Therapy for Type 2 DM and NAFLD

This study is currently recruiting patients.
Verified by National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) March 2006

Sponsored by: National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive
and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00230087

Purpose

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.
Condition Intervention Phase
Non-Alcoholic Fatty Liver Disease
Diabetes Mellitus
Procedure: iron depletion by phlebotomy
Phase II

MedlinePlus related topics: Diabetes

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled,
Single Group Assignment, Efficacy Study

Official Title: Iron Depletion Therapy for Patients With Type 2
Diabetes Mellitus and Non-Alcoholic Fatty Liver Disease

Further study details as provided by National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK):
Primary Outcomes: · Improved insulin sensitivity as determined by:;
(1) hyperinsulinemic euglycemic clamp method; (2) HOMA model-
determined by the OGTT method
Secondary Outcomes: · Change in serum aminotransferase levels; ·
Change in levels of serum, plasma and urinary markers of oxidative
stress; · Changes in intrahepatic and intraabdominal fat content as
determined by CT scan; · Change in serum levels of proinflammatory
cytokines (ie IL-6, TnF-aR2)
Expected Total Enrollment: 15
Study start: September 2005; Expected completion: January 2008
Last follow-up: October 2007; Data entry closure: December 2007

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.

Eligibility

Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible
for Study: Both
Criteria
Inclusion Criteria

Histological evidence of NAFLD and enrollment in NASH CRN Database
Study
Type 2 DM treated with diet or a stable dose of non-insulin sensitizing
oral hypoglycemic agents for > 3 mo.
Hemoglobin HbA1c level = 8 %
Serum ALT levels =1.3 x ULN
Between 18-65 years of age
Exclusion Criteria

Hereditary hemochromatosis or hepatic iron overload defined as any of
the following:

2+ iron on hepatic iron staining
Hepatic Iron Index = 1.9
C282Y homozygous or C282Y/H63D compound heterozygous HFE genotype
Use of insulin or thiazolidinediones for the treatment of diabetes
Use of anti-NASH drugs (thiazolidinediones, vitamin E, UDCA, SAM-e,
betaine, milk thistle, gemfibrozil, anti-TNF therapies, probiotics)
Serum ferritin <50µg/L
Serum transferrin-iron saturation <10 %
Hemoglobin <10 mg/L
Hematocrit <38 %
Voluntary blood donation or therapeutic phlebotomy within the previous
twelve months (except routine lab tests)
Pregnant or lactating women
Prior history of coronary artery disease, myocardial infarction,
exertional dyspnea or chronic chest pain at rest.
Evidence of myocardial infarction as determined by an ECG
Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier
NCT00230087

Jim E Nelson, PhD 206-221-4537 jamesn@medicine.washington.edu
Virginia Mugford, BS 206-221-4538
virginiam@medicine.washington.edu

Washington
University of Washington Medical Center, Seattle, Washington,
98195, United States; Recruiting
Jim Nelson, PhD 206-221-4537 jamesn@medicine.washington.edu

Study chairs or principal investigators

Kris V Kowdley, MD, Principal Investigator, University of Washington

More Information

Study ID Numbers: DK 61728-S1
Last Updated: March 6, 2006
Record first received: September 29, 2005
ClinicalTrials.gov Identifier: NCT00230087
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-06-28

U.S. National Library of Medicine, Contact NLM Customer Service
National Institutes of Health, Department of Health & Human Services
Copyright, Privacy, Accessibility, Freedom of Information Act

Who loves ya.
Tom

Jesus Was A Vegetarian!
http://jesuswasavegetarian.7h.com

Man Is A Herbivore!
http://tinyurl.com/a3cc3

DEAD PEOPLE WALKING
http://tinyurl.com/zk9fk

outsor@citynet.net · medicine forum Guru Joined: 11 Sep 2005 Posts: 569

The real question is why some diabetics have elevated iron levels, what is
it about this disorder that promotes it? We already know iron is not the
cause of diabetes. We know that diabetes is the perfect way to show that
the iron causes all disease because people eat meat notion is false.

Kumar · medicine forum Guru Joined: 10 May 2005 Posts: 870

outsor@citynet.net wrote:

Google