Iron Reduction for the Treatment of Diabetes and Nonalcoholic Fatty Liver Disease
NCT ID: NCT03696797
Last Updated: 2025-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
68 participants
INTERVENTIONAL
2019-05-03
2025-01-03
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment Group
Will have a Unit of blood (two cups, the same amount donated at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure your blood count to be sure you are not anemic, and blood pressure to be sure no dehydration. During or after donation, a sports drink is provided to replace the fluid loss. Phlebotomy
Blood Donation
Participants in the TREATMENT GROUP will have a Unit of blood (two cups, the same amount you would donate at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure blood count to be sure participants are not anemic, and blood pressure to be sure there is no dehydration. During or after donation, participants will be given a sports drink to replace the fluid loss. Participants in the CONTROL GROUP will not donate blood, but will have a needle inserted into a vein in your arm. Neither group will not know to which they have been assigned, all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so they will not know whether blood was actually removed.
Control Group
Will not donate blood, but will have a needle inserted into a vein in your arm. Both groups will not know which group assignment they have been randomized. Sham Phlebotomy
Sham Blood Donation
Participants will have a needle inserted their arm, however, no blood will be drawn.
Interventions
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Blood Donation
Participants in the TREATMENT GROUP will have a Unit of blood (two cups, the same amount you would donate at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure blood count to be sure participants are not anemic, and blood pressure to be sure there is no dehydration. During or after donation, participants will be given a sports drink to replace the fluid loss. Participants in the CONTROL GROUP will not donate blood, but will have a needle inserted into a vein in your arm. Neither group will not know to which they have been assigned, all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so they will not know whether blood was actually removed.
Sham Blood Donation
Participants will have a needle inserted their arm, however, no blood will be drawn.
Eligibility Criteria
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Inclusion Criteria
* At least 3 months since diagnosis of prediabetes or diabetes
* HgbA1C value within three months or at screening of 5.7-6.4% for those with prediabetes and 7- 8.5% for those with diabetes (the upper limit of the latter to reduce the likelihood of major changes in glycemic intervention during the trial period, and the lower limit to allow some room for improvement)
* Undiagnosed on no medication HgA1C 6.5-6.9
* C-reactive protein levels up to 11.0
* Aim 2-serum ALT\> 1.5 times the upper limit of normal, or; liver stiffness of \> 12.5 kPa by Fibroscan transient elastography
* Serum ferritin levels within 1 year or at the time of screening in the upper half of the normal range (\>50 ng/mL for women; \>100ng/mL for men)
Exclusion Criteria
* Hemoglobin levels within 0.5 g/dL of the lower limit of normal (\<12.5 g/dL for women; 13.5 g/dL for men)
* Recent blood loss
* Bleeding diatheses (coagulation abnormalities or treatment with anticoagulants)
* Serious chronic infections or chronic inflammatory conditions that could elevate ferritin as an "acute phase reactant
* C-reactive protein greater than the upper limit of normal to further validate the lack of significant chronic inflammation
* Active cancer diagnosis (excluding skin cell cancers other than melanoma)
* Renal insufficiency (eGFR\<60 ml/min)
* History of orthostatic hypotension
* Heavy alcohol use (NIH criteria for men, greater than 4 drinks on any day or 14/week)
* Pregnancy or premenopausal women of childbearing age, unless unable to become pregnant because of oral contraceptive use or surgical loss of ovaries or uterus
40 Years
75 Years
ALL
No
Sponsors
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University of North Carolina, Chapel Hill
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Donald A McClain, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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University of North Carolina at Chapel Hill (UNC)
Chapel Hill, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Countries
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References
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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IRB00044393
Identifier Type: -
Identifier Source: org_study_id
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