CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 132 enrolled / 132 target
Drug / intervention
Blood Donation +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03696797
NCT03696797N/ACompletedOn Track (1.5/mo)Completion was 17mo ago
CompareCT.gov

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

Wake Forest University Health Sciences·interventional·Posted Oct 5, 2018·Updated Jun 9, 2026

In Brief

A clinical study evaluating Blood Donation and Sham Blood Donation for Iron and 2 related conditions. Completed, enrolled 132 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIron, Diabetes, Nonalcoholic Fatty Liver
CountriesUnited States
CollaboratorsUniversity of North Carolina, Chapel Hill, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 5, 2018
Enrollment StartMay 3, 2019
Primary CompletionJan 3, 2025
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 7.7 years ago

Arms & Interventions

Treatment Groupactive_comparator

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

Procedure: Blood Donation
Control Groupsham_comparator

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

Procedure: Sham Blood Donation

Interventions

Blood Donationprocedure

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 Donationprocedure

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