> http://www.forbes.com/forbeslife/health/feeds/hscout/2006/10/02/hscout535241.html
>
[quoted text clipped - 50 lines]
> experiment we've got going here in the US.
> TC
>>Could it be that the massive load of grains in the SAD diet is causing
fatty livers in children? Hmmmm. Quite the societal-nutritional
experiment we've got going here in the US.
TC<<
Only if you showed the same .. rate .. in vegetarian children.
They have shown a direct correlation between increased iron levels and
NAFLD .. so much so .. that they have begun a .. study ..
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 jam...@medicine.washington.edu
Virginia Mugford, BS 206-221-4538
virgin...@medicine.washington.edu
Washington
University of Washington Medical Center, Seattle, Washington,
98195, United States; Recruiting
Jim Nelson, PhD 206-221-4537 jam...@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
TC - 04 Oct 2006 15:04 GMT
> > http://www.forbes.com/forbeslife/health/feeds/hscout/2006/10/02/hscout535241.html
> >
[quoted text clipped - 55 lines]
> experiment we've got going here in the US.
> TC<<
> Only if you showed the same .. rate .. in vegetarian children.
Do you have anything that shows otherwise? How do you know that that
numbers do not include vegetarian children?
TC
> They have shown a direct correlation between increased iron levels and
> NAFLD .. so much so .. that they have begun a .. study ..
[quoted text clipped - 163 lines]
> DEAD PEOPLE WALKING
> http://tinyurl.com/zk9fk