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临床试验/NCT04614116
NCT04614116已完成不适用

Cold Induced Futile Cycles In White Adipose Tissue: Quantification And Characterization With Dual Glucose Analysis

Kantonsspital Baden2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
2
主要终点
Comparison of FDG influx into WAT

研究概览

简要总结

Investigation of futile cycles in white adipose tissue under cold conditions for thermogenesis using two substitutes for glucose metabolism (18F-FDG and 13C-Glucose).

详细描述

Thermogenesis is defined as a process, which generates heat by the depletion of energy-rich molecules. Evolutionary, it is an essential process that allows the survival at lower temperatures. Since the discovery of brown adipose tissue (BAT) it is believed that this part of the adipose tissue can dissipate energy for heat thanks to the uncoupling protein 1 (UCP1). Since energy expenditure is increased as a consequence of thermogenesis, pharmacological induction of this pathway presents an interesting therapeutic target to counter obesity. However, recent investigations indicate that white adipose tissue (WAT) is much more versatile and probably essentially indispensable for thermogenesis.

To investigate the mechanism of this futile cycle in WAT we plan to investigate the glucose metabolism in 24 healthy volunteers with 2 exams (one with and one without external cooling) with two substitutes for glucose. We will use 18F-FDG to quantify the glucose influx into WAT using dynamic PET/CT scans and 13C-Glucose to analyze the downstream metabolites.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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
Male
接受健康志愿者

入选标准

  • Informed Consent as documented by signature
  • Healthy participants, as determined by screening assessments and Principal Investigator's judgment
  • Health status is defined by the absence of evidence of any active or chronic disease following a medical and surgical history, basic physical examination and blood test

排除标准

  • any clinically relevant history or the presence of e.g. respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric, metabolic disease, etc.
  • Intake of the following medications: Insulin, oral antidiabetic drugs, GLP-1-agonists, Corticosteroids, Sympathomimetic and Sympatholytic drug, Beta-Blocker, Statins.
  • BMI > 35 kg/m2
  • Resting pulse rate > 70 bpm, resting blood pressure > 130/90 mmHg.
  • Serum creatinine > 145 µmol/L
  • ASAT> 75 U/L and ALAT > 75 U/L
  • γ GT > 100 UI/L and total bilirubin > 30 µmol/l
  • Glucose > 7.1 mmol/L
  • HbA1c > 46 mmol/mol (>6.4%)
  • Intake of anticoagulants or inhibitors of platelet aggregation (e.g. Aspirin, clopidogrel).
  • Known tendency to form keloids (hypertrophic scar tissue)
  • Known or suspected non-compliance, drug or alcohol abuse,
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
  • Participation in another study with investigational drug within the 30 days preceding and during the present study
  • Participation in another study involving ionizing radiation in the same year
  • Previous enrolment into the current study,
  • Enrolment of the investigator, his/her family members, employees and other dependent persons

结局指标

主要结局

Comparison of FDG influx into WAT

时间窗: 2 days

Comparing the 18F-FDG influx rate (Ki) into the white adipose tissue with and without cold stimulation (intra-individually).

次要结局

  • Quantification of 13C-Glucose metabolites in fat(2 days)
  • Quantification of 13C-Glucose metabolites in blood(2 days)

研究者

发起方
Kantonsspital Baden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Irene A. Burger

Head of clinic

Kantonsspital Baden

研究点 (2)

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