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临床试验/NCT02563834
NCT02563834已完成不适用

A Novel Positron Emission Tomography (PET) Approach to Measuring Myocardial Metabolism

Indiana University1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2007年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
Myocardial Fatty Acid Uptake Rate

研究概览

简要总结

Studies of myocardial fuel selection using a novel palmitate-based PET probe

详细描述

A novel Positron Emission Tomography (PET) probe, 16- 18-F-fluoro-4-thiapalmitate, will be used to evaluate myocardial atty acid uptake. Studies will be done in humans with type 2 diabetes mellitus, and in controls. Studies will take place on 2 separate days, under fasting conditions and under insulin clamp conditions.

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI<25 kg/m2
  • normal glucose tolerance by 75g oral glucose tolerance test
  • Type 2 diabetes mellitus:
  • BMI >25 kg/m2
  • previously diagnosed type 2 diabetes mellitus
  • on oral and/or injected insulin treatment.

排除标准

  • *Use of any chronic medications
  • Type 2 diabetes mellitus
  • known microvascular disease
  • known coronary or other macro vascular disease
  • use of PPARgamma class antidiabetic agents within 6 months

研究组 & 干预措施

Saline

Experimental

Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).

干预措施: thiapalmitate tracer (Drug)

Saline

Experimental

Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).

干预措施: Saline (Drug)

Insulin Clamp

Experimental

Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).

干预措施: thiapalmitate tracer (Drug)

Insulin Clamp

Experimental

Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).

干预措施: Insulin (Drug)

结局指标

主要结局

Myocardial Fatty Acid Uptake Rate

时间窗: 4 Hours

PET measure of fatty acid uptake rate

次要结局

  • Myocardial Perfusion Rate(4 Hours)
  • Myocardial Oxidation Rate(4 Hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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