Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

COMPLETED

NCT03696797

Iron Reduction for the Treatment of Diabetes and Nonalcoholic Fatty Liver Disease

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

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.

Official title: Iron Reduction by Phlebotomy for the Treatment of Diabetes and Nonalcoholic Fatty Liver Disease

Key Details

Gender

All

Age Range

40 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2019-05-03

Completion Date

2025-01-03

Last Updated

2026-06-09

Healthy Volunteers

Conditions

Iron Diabetes Nonalcoholic Fatty Liver

Interventions

PROCEDURE

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.

PROCEDURE

Sham Blood Donation

Participants will have a needle inserted their arm, however, no blood will be drawn.

Inclusion Criteria: * Ages 40-75 * 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: * Documented anemia * 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 * Aim 2 - individuals meeting the additional inclusion criteria for aim 2 will be tested for anti-HAV IgM, HBs Ag, anti-HBc. IgM, anti HCV IgM and IgG. Subjects who prove positive for any of these viral serologies, except for HCV IgG will be excluded. The latter will be tested for HCV RNA by PRC, and if negative they will be eligible for enrollment

Locations (2)

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