Iron Reduction by Phlebotomy to Improve Diabetes Control
https://clinicaltrials.gov/ct2/show/NCT03696797
ClinicalTrials.gov Identifier: NCT03696797
First Posted : October 5, 2018
Wake Forest University Health Sciences
Collaborator:
University of North Carolina, Chapel Hill
Wake Forest University Health Sciences
Study Details
Brief Summary:
This is a treatment study to determine if reducing the body's iron stores by blood donation will improve diabetes control and other problems associated with diabetes such as fatty liver disease.
Detailed Description:
Investigators propose that high iron triggers a number of events in different tissues, some of which will predispose to diabetes. Investigators will therefore study normal individuals who have higher than average iron levels in tissues, test your glucose
control through standard blood tests like the hemoglobin A1c and by placing a continuous glucose monitor before and after participants have donated blood to determine if decreasing iron levels had any effect.
In addition, iron may also play a role in the progression of fatty liver to scarring and cirrhosis. Since 75% of people with diabetes have some degree of fatty liver, investigators would also like to study how the liver reacts to the lowering of iron.
There will be two optional sub studies conducted only at Wake Forest University Health Sciences they are: 1) Liver substudy that will look at liver complication of diabetes and the role it plays in the progression of fatty liver to scarring and cirrhosis.
Investigators will look at how liver reacts to the lowering of iron. 2)Glucose Tolerance Mechanism substudy that will look at the mechanism the body uses to regulate blood sugar levels by insulin, this will require the frequently sample intravenous
glucose tolerance test (FSIVGTT).
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