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Effect of Iron Reduction by Phlebotomy for Type 2 Diabetes

NCT02468037 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-06-10

No results posted yet for this study

Summary

High tissue iron is a risk factor for diabetes even within the broad normal range of normal human values. In order to demonstrate the benefits of reducing iron on glucose homeostasis and to better define the parameters for larger clinical trials, the investigators will subject individuals with prediabetes (impaired glucose tolerance, IGT) or early type 2 diabetes to phlebotomy in order to reduce serum ferritin concentrations and determine the effect on glucose homeostasis as revealed by oral and frequently sampled intravenous glucose tolerance testing.

Conditions

Interventions

PROCEDURE

Phlebotomy

Patients donate blood until tissue iron levels are in the lowest quartile of normal.

Sponsors & Collaborators

  • University of Colorado, Denver

    collaborator OTHER

  • University of New Mexico

    collaborator OTHER

  • University of Utah

    lead OTHER

Principal Investigators

  • Donald McClain, MD, PhD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2015-05-31
Completion
2015-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02468037 on ClinicalTrials.gov