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

NCT03696797 | Completed DMC

• 2 other identifiers: IRB000443931R01DK119913-01
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

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.

Conditions

Iron; Diabetes; Nonalcoholic Fatty Liver

Keywords

Iron Reduction; Phlebotomy

Outcome Measures

Primary Outcomes (3)

• Change in HgbA1C

  Change in glycemia as measured byHgbA1C. Values from baseline and month 6 will be reported.

  Baseline, Month 6

• Change in ALT

  ALT values from baseline and month 12 will be reported.

  Baseline, Month 12

• Change in FSIGTT DI (Frequently sampled intravenous glucose tolerance test)

  FSIGTT DI Values from baseline and month 6 will be reported.

  Baseline, Month 6

Secondary Outcomes (8)

• HgbA1C at Month 12

  Month 12

• Change in fasting glucose

  Month 6, Month 12

• Change in HOMA-IR (Homeostatic Model Assessment-Insulin Resistance)

  Baseline, 12 months

• Number of participants that Discontinued of oral antihyperglycemic agent

  Month 12

• Change in Weight

  Baseline, Month 12

Study Arms (2)

Treatment Group

ACTIVE 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 Group

SHAM 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 Donation PROCEDURE

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.

Treatment Group

Sham Blood Donation PROCEDURE

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

Control Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• University of North Carolina, Chapel Hill: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

University of North Carolina at Chapel Hill (UNC)

Chapel Hill, North Carolina, 27599-2100, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (40)

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MeSH Terms

Conditions

Diabetes Mellitus; Non-alcoholic Fatty Liver Disease

Interventions

Blood Donation

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Tissue and Organ Procurement; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Donald A McClain, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Both groups will not know assignment as all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so participant will not know whether blood was actually removed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 5, 2018
• Study Start: May 3, 2019
• Primary Completion: January 3, 2025
• Study Completion: January 3, 2025
• Last Updated: April 2, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)