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临床试验/NCT03348020
NCT03348020已完成不适用

Iron Homeostasis, Adipose Tissue Lipolysis, and Insulin Resistance in Overweight and Obese Humans

University of Michigan2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Change in insulin sensitivity after blood donation

研究概览

简要总结

Determine the effects of reducing whole-body iron stores in overweight/obese subjects (via one-time blood donation) on adipose tissue iron content, factors regulating iron homeostasis and lipolytic rate in adipose tissue, as well as measures of adipose tissue and whole-body insulin resistance.

After a screening visit to determine eligibility, subjects will undergo a battery of tests for the determination of primary outcome measures at baseline. They will then donate 1 unit (~500 mL) of blood (at a local blood donation center) and return for a follow-up testing 4 weeks after blood donation. During the 4-week period between study trials, subjects will be required to maintain a stable body mass and not alter their dietary or physical activity habits.

详细描述

Screening:

If a potential subject meets the eligibility criteria after completing the general pre-screening questionnaire, they will be contacted to set up an in-person screening visit where the comprehensive written informed consent will be obtained. This visit may occur either at the Michigan Clinical Research Unit (MCRU) or at the Substrate Metabolism Laboratory (SML). Subjects will complete health history, food frequency, and physical activity questionnaires. Subjects that meet eligibility requirements and provide written informed consent will have a finger-stick performed for the assessment of hemoglobin concentration. Women with hemoglobin < 13.0 g/dL and men with hemoglobin < 14.0 g/dL will be withdrawn from the study.

Percent body fat will be measured using Dual Energy X-ray Absorptiometry [DEXA]. Women will provide a urine sample for a urine pregnancy test prior to the DEXA scan; if a subject has a positive pregnancy test prior to the DEXA scan, they will be withdrawn. The DEXA body composition assessment test may be performed at the screening visit or scheduled anytime between the screening visit and the baseline trial.

Baseline Trial:

Subjects will be provided general instructions on what to eat in the 3 days leading up to their baseline trial and be required to abstain from planned exercise in the 3 days leading up to the baseline and post-blood donation study trials. They will record their dietary intake during the 3 days leading up to the baseline trial and replicate it during the 3 days prior to the post-blood donation study trial. They will be required to fast the night before the trials starting at 9:00PM.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in insulin sensitivity after blood donation

时间窗: 1 month

A hyperinsulinemic-euglycemic clamp will be used to assess insulin sensitivity. The change in the glucose infusion rate will be used to measure the insulin sensitivity after blood donation.

次要结局

  • Change in lipolytic rate after blood donation(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeffrey F Horowitz

Professor, Movement Science and Director, Substrate Metabolism Laboratory

University of Michigan

研究点 (2)

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