Clinical Trials

Iron-Induced Oxidative Stress and Mitochondrial Dysfunction: Effects on Insulin Secretion and Insulin Sensitivity

Study Description

Participants will first be tested to determine if they have high levels of iron, and if so, why.  They will then undergo a two night stay in a hospital clinic and have the following tests:  indirect calorimetry test, Oral Glucose Tolerance Test, Intravenous (IV) glucose tolerance test, and a DEXA scan to determine body fat and bone density.  The overnight stays are to insure an early start to the study and to confirm the fasting state.

Participants will then be required to give about 3-6 blood donations over approximately 12 months to lower their iron levels to the lowest quarter of the normal range.  They will then be retested to determine what effects the lower iron levels has made to their body's metabolism. 

Objectives

Primary Objective(s):

To study the role of iron in diabetes.  Specifically, to study if reducing the level of iron in individuals who have iron overload from diet or other non-hemochromatosis mechanisms has implications for the therapy and/or prevention of Type 2 Diabetes.

Contact Information

Status:

Name, Phone, Email:
Deborah Burton, RN,
801-585-6745 or
801-585-1566
Deborah.burton@hsc.utah.edu

Principle Investigator:
Donald McClain, M.D., PhD

Please Note:

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician, we can help you find a University of Utah doctor or clinic location to meet your health care needs.

Although the studies described on this Web site may have potential benefits as described, the University of Utah and its physicians and affiliated hospitals cannot and do not guarantee or promise that you will receive any benefits from participating in a study.

Participant Eligibility

Inclusion Criteria:
  1. Individuals from 40-69 years of age.
  2. Individuals with high iron levels.
Exclusion Criteria:
  1. Diabetes (by history, or fasting glucose >126 mg/dl).
  2. Hemochromatosis (Iron Overload) Disease (genetic).
  3. Prednisone use within 2 months.
  4. History of recent (<1 year) blood loss or increased bleeding risk indluding history of coumadin therapy, low blood platelets, or low clotting factors.
  5. A diagnosis of cancer (unless currently with no evidence of disease)
  6. Renal Failure (serum creatinine >1.5).
  7. Hepatitis C or Hepatitis B.
  8. Other serious illness leading to an inflammatory state or elevated C-reactive protein.
  9. Women who have not yet undergone menopause.

How long does the study run?

Study will run for 5 years.

Location(s) of the Clinical Trial

University of Utah Medical Center
Salt Lake City, UT 84132