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临床试验/NCT01658397
NCT01658397已完成不适用

The Effect of Calorie Deprivation on Adipose Tissue Distribution

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Change in Bone Marrow Adiposity over 10 day fasting period

研究概览

简要总结

In this study, we will be studying the effects of acute calorie deprivation (a 10-day fast) on bone marrow fat, other fat stores and bone parameters. We will be measuring changes in bone marrow fat using magnetic resonance spectroscopy and will use MRI to measure subcutaneous and visceral fat depots. Our hypothesis is that levels of bone marrow fat will increase after an acute fast.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Men and women, ages 21-45 years
  • 101-130% of ideal body weight as defined by the 1983 Metropolitan Life Insurance Height and Weight Tables
  • Normal thyroid function
  • Regular menses (women)
  • Normal liver transaminases

排除标准

  • Any disease known to affect bone metabolism, including untreated thyroid dysfunction, Cushing's syndrome, or renal failure
  • Any medication known to affect bone metabolism -- including systemic steroids or immunosuppressants -- within three months of the study, excluding estrogen and progestins. Patients receiving depot medroxyprogesterone (Depo-Provera) will be excluded from participating for six months after their last injections. Bisphosphonates must have been discontinued for at least one year before participation
  • Serum potassium <3.0 meq/L
  • Pregnant and/or breastfeeding (women)
  • Diabetes mellitus
  • Active substance abuse, including alcohol
  • Contraindications to MRI: cardiac pacemaker, metal implants, claustrophobia

结局指标

主要结局

Change in Bone Marrow Adiposity over 10 day fasting period

时间窗: Baseline, After 10 day fasting period

Bone marrow adiposity will be measured before and after the 10 day fast using magnetic resonance spectroscopy.

次要结局

未报告次要终点

研究者

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

Pouneh K. Fazeli, MD

Assistant Professor of Medicine

Massachusetts General Hospital

研究点 (2)

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