Iron Reduction by Phlebotomy to Improve Diabetes Control

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 3, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

December 2018

Estimated Primary Completion Date

November 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in HgbA1C[ Time Frame: Baseline, Month 6 ]

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

Change in ALT[ Time Frame: Baseline, Month 12 ]

ALT values from baseline and month 12 will be reported.

Change in FSIGTT DI (Frequently sampled intravenous glucose tolerance test)[ Time Frame: Baseline, Month 12 ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

HgbA1C at Month 12[ Time Frame: Month 12 ]
HgbA1C values will be reported.
Change in fasting glucose[ Time Frame: Month 6, Month 12 ]
Fasting glucose measured on glucose machine (Abbott Freestyle Libre Pro system). Values of month 6 and month 12 will be reported.
Change in HOMA-IR (Homeostatic Model Assessment-Insulin Resistance)[ Time Frame: Baseline, 12 months ]
Insulin sensitivity measured by HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) calculated from fasting glucose and insulin. Values will be reported for Baseline and 12 months.
Number of participants that Discontinued of oral antihyperglycemic agent[ Time Frame: Month 12 ]
The numbers of participants that discontinued of oral antihyperglycemic agents
Change in Weight[ Time Frame: Baseline, Month 12 ]
The change in weight from baseline to month 12 will be reported
Change in Blood Pressure[ Time Frame: Baseline, Month 12 ]
The change in Blood pressure from baseline to month 12 will be reported
Number of participants that converted from pre-diabetes to Diabetes[ Time Frame: Month 12 ]
Number of participants that converted from pre-Diabetes to Diabetes based on the HbA1C criteria.
Number of participants that converted from pre-diabetes to normal glucose tolerance[ Time Frame: Month 12 ]
Number of participants that converted from pre-Diabetes to normal glucose tolerance based on the HbA1C criteria.

Descriptive Information

Brief Title ^ICMJE

Iron Reduction by Phlebotomy to Improve Diabetes Control

Official Title ^ICMJE

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

Brief Summary

This is a treatment study to determine if reducing the body's iron stores by blood donation will improve your diabetes control and other problems associated with diabetes such as fatty liver disease.

Detailed Description

Investigators propose that high iron triggers a number of events in different tissues, some of which will predispose to diabetes. Investigators will therefore study normal individuals who have higher than average iron levels in tissues, test your glucose control through standard blood tests like the hemoglobin A1c and by placing a continuous glucose monitor before and after you have donated blood to determine if decreasing your iron levels had any effect. In addition, iron may also play a role in the progression of fatty liver to scarring and cirrhosis. Since 75% of people with diabetes have some degree of fatty liver, investigators would also like to study how the liver reacts to the lowering of iron. There will be two optional sub studies conducted only at Wake Forest University Health Sciences they are: 1) Liver substudy that will look at liver complication of diabetes and the role it plays in the progression of fatty liver to scarring and cirrhosis. We will look at how your liver reacts to the lowering of iron. 2)Glucose Tolerance Mechanism substudy that will look at the mechanism your body uses to regulate blood sugar levels by insulin, this will require the frequently sample intravenous glucose tolerance test (FSIVGTT).

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description: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.
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Procedure: Phlebotomy
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.
Procedure: Sham Phlebotomy
Participants will have a needle inserted their arm, however, no blood will be drawn.

Study Arms

Active Comparator: Treatment Group
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
Sham Comparator: Control Group
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

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

120

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

November 2023

Estimated Primary Completion Date

November 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - 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 improvement) - Serum ferritin levels within 1 year or at the time of screening in the upper half of the normal range (>85 ng/mL for women >110ng/mL for men) Exclusion Criteria: - Documented anemia - Hemoglobin levels with 0.5 g/dL of the lower limit of normal (<12.52 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 me 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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

40 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Wake Forest University Health Sciences

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Donald A McClain, MD, PhD Wake Forest University Health Sciences

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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