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临床试验/NCT06830486
NCT06830486已完成不适用

The Effects of Cardiorespiratory Fitness, Physical Activity and Sedentary Behavior on Insulin Resistance Among Breast Cancer Survivors Being Treated With Anti-estrogen Endocrine Therapies

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年2月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Insulin Resistance

研究概览

简要总结

The aim of this study is to learn more about how physical activity and cardiorespiratory fitness are related to diabetes risk among breast cancer patients prescribed an endocrine therapy.

详细描述

80 women between the ages of 18-80 years will be recruited for this study. The study design consists of two separate in-person visits to University of Colorado Anschutz Medical Campus or Colorado State University. The study consists of glucose testing, a body composition scan, exercise testing, and a two-week period of free living activity monitoring.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • diagnosed with breast cancer
  • age 18-80 years
  • Completed surgery, chemo- and/or radiation therapy
  • Prescribed aromatase inhibitor or SERM for at least one year from the time of screening

排除标准

  • Age < 18 or > 80
  • Type 1 diabetes
  • Type 2 diabetes
  • Prescribed anti-hyperglycemic medication, insulin, or sulfonylurea.
  • Pregnant, breastfeeding or planning to become pregnant in next 2 months
  • Have absolute contraindications to exercise testing which are:
  • Unstable angina
  • Recent myocardial infarction, cardiac surgery, or vascular surgery (<3 months)
  • Uncontrolled high blood pressure
  • Heart failure
  • Peripheral artery disease (based on report of symptomatic claudication)
  • Hepatic or renal disease
  • Severe arthritis or mobility impairment that would interfere with exercise testing
  • Suspected cognitive impairment that would prevent understanding or comprehension of study procedures.

研究组 & 干预措施

SERM

These patients are being treated with a SERM for at least one year prior to enrolling in the study.

干预措施: No intervention (Other)

Aromatase Inhibitor

These patients are being treated with an aromatase inhibitor for at least one year prior to enrolling in the study.

干预措施: No intervention (Other)

结局指标

主要结局

Insulin Resistance

时间窗: Immediately after the consent form is signed

Insulin resistance will be measured through oral glucose tolerance testing

Body Composition

时间窗: Immediately after the insulin resistance measurement

Body composition will be measured through DEXA scan

Maximal Exercise Capacity

时间窗: Within 2-60 days of insulin resistance measurement

Maximal exercise capacity measured through graded exercise test on stationary bicycle

Daily Activity

时间窗: 2-60 days following insulin resistance measurement

Daily activity measured using activity monitor

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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