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临床试验/NCT03289559
NCT03289559已完成不适用

Testosterone Effects on Systemic Lipolysis and Whole Body Lipid Utilization

University of Colorado, Denver0 个研究点目标入组 13 人开始时间: 2006年1月1日最近更新:
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
13
主要终点
Dietary fat tracer for storage of meal derived fatty acids

研究概览

简要总结

Evidence is accumulating that there are sex differences in energy and substrate metabolism. The positive or negative consequences of such metabolic differences between men and women need to be evaluated with respect to health outcomes. The importance of aberrant lipid metabolism in metabolic diseases such as obesity, diabetes and cardiovascular disease, makes understanding the distinction between "normal" vs aberrant critical to future treatment and prevention strategies. Sex differences in the effects of catecholamines on lipid metabolism and substrate oxidation in non-obese, healthy individuals, have been consistently observed. In addition, distinct differences in men and women exist in the distribution of body fat, with men typically having greater central adiposity than women. Accumulation of fat in the abdomen is associated with an increased risk for metabolic abnormalities such as hyperlipidemia and insulin resistance. In the current study, therefore, the role of testosterone in determining the sex differences in catecholamine mediated substrate metabolism and deposition of dietary fat into upper versus lower body adipose tissue depots will be addressed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • normal weight (BMI of 23-29.9 kg/m2)
  • not be highly trained (< 5hrs of moderate intensity, planned exercise per week).

排除标准

  • Patients will be excluded if they have one or more of the following out-of-range values measured on a fasting blood sample:
  • glucose <65 or > 110 mg/dl,
  • insulin > 20 uU/ml,
  • thyroid stimulating hormone <0.5 or >5.0 uU/ml,
  • growth hormone >2.5 ng/ml.
  • Subjects who may be:
  • anemic (hemoglobin < 14.5 g/dl men ),
  • have abnormal liver function tests:
  • alanine amino transferase > 47 U/l,
  • aspartate aminotransferase, > 47 U/l,
  • alkaline phosphatase <39 or >117 U/l) or
  • creatinine (<0.6 or >1.1 mg/dl).

研究组 & 干预措施

GnRH antagonist + Placebo Gel

Placebo Comparator

干预措施: GnRH antagonist (Drug)

GnRH antagonist + Placebo Gel

Placebo Comparator

干预措施: Aromatase Inhibitors (Drug)

GnRH antagonist + Testosterone Gel

Active Comparator

干预措施: GnRH antagonist (Drug)

GnRH antagonist + Testosterone Gel

Active Comparator

干预措施: Aromatase Inhibitors (Drug)

GnRH antagonist + Testosterone Gel

Active Comparator

干预措施: Testosterone gel (Drug)

结局指标

主要结局

Dietary fat tracer for storage of meal derived fatty acids

时间窗: 4 weeks

50 uCi of \[1-14C\] oleic acid administered with an inpatient test meal

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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