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临床试验/NCT00438321
NCT00438321终止1 期

Effect of Increasing Testosterone on Insulin Sensitivity in Men With the Metabolic Syndrome

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2006年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
终止
入组人数
66
试验地点
1
主要终点
Insulin sensitivity

研究概览

简要总结

The purpose of the study is to examine the effect of testosterone treatment on insulin in men with the metabolic syndrome with testosterone levels at or below the lower end of the normal range.

详细描述

The metabolic syndrome is a medical condition defined by high cholesterol levels, high blood pressure, increased abdominal obesity (gain in fat around the region of the stomach), and insulin resistance. Insulin is the hormone that your body produces to decrease the levels of sugar in your blood. A person that is insulin resistant needs more insulin to decrease blood sugar levels than a normal person does. Insulin resistance can lead to type 2 diabetes, which is one of the most common illnesses in the United States.

There is evidence pointing to a relationship between insulin and testosterone in men (testosterone is the male sex hormone that is produced in the testes). As men get older their testosterone levels decrease while their weight and insulin resistance tends to increase. The purpose of this research study is to learn more about the details of the relationship between insulin and testosterone. A clearer understanding of this relationship can have an important impact on public health due to the high rate of health problems associated with diabetes, obesity, and heart disease.

We are looking for men between the ages of 50-75 with the metabolic syndrome to participate in this research study. Participation in this study involves taking medication and/or placebo (a placebo looks exactly like the study medication but contains no active drug), blood tests, muscle biopsies, and imaging scans. This study involves outpatient visits. Subjects are paid up to $500 for completing the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Stable weight for previous three months (no weight change greater than or equal to +/-10 lbs)

排除标准

  • No new diagnosis of type 2 diabetes or on oral hypoglycemic agents
  • No history of testicular disorders
  • No history of bleeding disorders (i.e. Pulmonary Embolism, Deep Vein Thrombosis, stroke, hypercoagulable syndrome)
  • No history of prostate cancer
  • No previous diagnosis of osteoporosis
  • No history of sleep apnea (subjects will also be excluded if at their baseline assessment they admit to heavy snoring, restless sleep, and/or excessive daytime somnolence)
  • No symptoms of urinary outflow obstruction or medications for prostate disease
  • No illicit drug use or heavy alcohol use (>4 drinks/day)

研究组 & 干预措施

Placebo

Placebo Comparator

Placebo injection, gel and pill

干预措施: Placebo (Other)

Testosterone only

Active Comparator

Zoladex 3.6 mg IM injection Testosterone 7.5 g gel (AndroGel) transdermally daily Anastrozole 10 mg (Arimidex) orally daily

干预措施: Anastrozole Pill (Drug)

Testosterone only

Active Comparator

Zoladex 3.6 mg IM injection Testosterone 7.5 g gel (AndroGel) transdermally daily Anastrozole 10 mg (Arimidex) orally daily

干预措施: Zoladex (Drug)

Testosterone only

Active Comparator

Zoladex 3.6 mg IM injection Testosterone 7.5 g gel (AndroGel) transdermally daily Anastrozole 10 mg (Arimidex) orally daily

干预措施: Testosterone gel (Drug)

Testosterone and Estrogen

Active Comparator

Zoladex 3.6 mg IM injection Testosterone 7.5 g gel (AndroGel) transdermally Placebo pill orally daily

干预措施: Zoladex (Drug)

Testosterone and Estrogen

Active Comparator

Zoladex 3.6 mg IM injection Testosterone 7.5 g gel (AndroGel) transdermally Placebo pill orally daily

干预措施: Testosterone gel (Drug)

结局指标

主要结局

Insulin sensitivity

时间窗: 3 months

Assessed by euglycemic-hyperinsulinemic clamp

次要结局

  • Body composition(3 months)
  • Resting energy expenditure(3 months)
  • Lipid profile(3 months)
  • Intramyocellular fat(3 months)

研究者

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

Frances Hayes

Associate Professor

Massachusetts General Hospital

研究点 (1)

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