Effect of Iron Reduction by Phlebotomy for Type 2 Diabetes

NCT02468037 | Completed DMC

• 1 other identifier: IRB_00020094
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief 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

Type 2 Diabetes Mellitus; Prediabetes

Keywords

iron; diabetes; phlebotomy

Outcome Measures

Primary Outcomes (1)

• Improvement in glucose area under the curve.

  As determined by oral glucose tolerance testing

  6 months after initiation of phlebotomy

Secondary Outcomes (2)

• Improvement in insulin sensitivity

  6 months after initiation of phlebotomy

• Improvement in insulin secretory capacity

  6 months after initiation of phlebotomy

Study Arms (2)

Phlebotomy

EXPERIMENTAL

All subjects receive counseling to follow a healthy diet and regular exercise. Phlebotomy occurs at the rate of 500 ml (one Unit) of blood per month over the period of 3-6 months. At two-month intervals, serum ferritin and complete blood counts are determined. When serum ferritin reaches the lowest quartile of normal (\<50 ng/mL for females and \<70 ng/mL for males, but no sooner than 3 months or later than 6 months after beginning phlebotomy, subjects will be retested for glucose tolerance as described

Procedure: Phlebotomy

Control

NO INTERVENTION

Subjects receive counseling to follow a healthy diet and regular exercise.

Interventions

Phlebotomy PROCEDURE

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

Phlebotomy

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 35-65
• Prediabetes, or diabetes relatively well-controlled (Hemoglobin A1c \[HbA1c\] ≤ 8.0%) with a single oral agent as defined by oral glucose tolerance testing (OGTT) using criteria of the American Diabetes Association.
• Serum ferritin values in the upper 50% of the normal range, 110-400 ng/mL for males, or 80-240 for females.

You may not qualify if:

• hereditary hemochromatosis;
• cancer (except cases currently with no evidence of disease);
• serum creatinine \>1.5;
• anemia (Hgb \< lower limit of normal);
• chronic inflammatory conditions (rheumatologic conditions such as rheumatoid arthritis or giant cell arteritis, or chronic infections such as hepatitis B or C) that could affect ferritin;
• erythrocyte sedimentation rate or C-reactive protein\>1.5 times the upper limit of normal (UNL);
• serum transaminases 2 x UNL;
• hemophilia,
• warfarin therapy,
• history of GI bleeding;
• current glucocorticoid therapy.

Sponsors & Collaborators

• University of Utah: lead
• University of Colorado, Denver: collaborator
• University of New Mexico: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Prediabetic State; Diabetes Mellitus

Interventions

Phlebotomy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Donald McClain, MD, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: June 4, 2015
• First Posted: June 10, 2015
• Study Start: April 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 10, 2015

Record last verified: 2015-06