Iron Reduction by Phlebotomy to Improve Diabetes Control

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追踪信息

首次提交日期 ^ICMJE

October 3, 2018

首次发布日期e ^ICMJE

October 5, 2018

最后更新发布日期

October 5, 2018

预计研究开始日期 ^ICMJE

December 2018

预计主要完成日期

November 2023 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^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.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^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.

描述性信息

简略标题 ^ICMJE

Iron Reduction by Phlebotomy to Improve Diabetes Control

正式标题 ^ICMJE

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

简要概况

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.

详细说明

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).

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述: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.
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^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.

研究工具

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

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

120

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

November 2023

预计主要完成日期

November 2023 (主要结果测量的最终数据收集日期)

合格标准 ^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.

性别

参与研究的性别:

All

年龄

最小年龄：40 Years ，最大年龄：75 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

United States

管理信息

数据检测委员会

Yes

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

，

研究赞助商 ^ICMJE

Wake Forest University Health Sciences

合作者 ^ICMJE

研究员 ^ICMJE

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

PRS 账户

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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