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临床试验/NCT03600675
NCT03600675已完成不适用

Determinants of Bone Mineral Density and Metabolic Syndrome in South Asian Indian Men

Drexel University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年5月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Bone Mineral Density ( g/cm2)

研究概览

简要总结

This study aims to examine the association between body composition with bone density and risk factors for cardiovascular disease and type 2 diabetes. South Asian Indians have a lower bone density and a higher likelihood to develop metabolic syndrome (MetS) compared to Caucasians. MetS is a cluster of metabolic abnormalities that predispose an individual to cardiovascular disease and type 2 diabetes. This study will understand if the metabolic and biochemical markers ( Indicators of bone building and breaking in the blood and urine, Lipids and other proteins) explain both low BMD and MetS in SAI men

详细描述

There is a rising minority population in the United States and South Asians make up the largest growing sub population. Health concerns in the minority population are several of which metabolic syndrome (MetS) and low bone mineral density (BMD) are important. Interestingly research in the past decade is beginning to suggest an interplay between bone and energy metabolism. Hormones, bone proteins and cytokines that play an important role in bone metabolism are also altered in metabolic syndrome, suggesting that both these

conditions may share a common etiology. Hence the primary question in this study would be to assess whether bone is altered in the South Asian population in the United States and whether hormones or other proteins regulating bone influence metabolic syndrome outcomes in the South Asians, specifically the South Asian Indian population. There is also an altered body composition in the South Asian Indian population with a greater visceral adiposity. Greater visceral adipose tissue (VAT) is associated in both the pathogenesis of metabolic syndrome and low BMD, possibly due to release of pro inflammatory cytokines. Interestingly several factors that are involved in the etiology of low BMD such as a greater visceral adiposity, high serum pro inflammatory cytokines, altered hormonal milieu such as low 25 hydroxy vitamin D (25OHD) and high parathyroid hormone (PTH), low osteocalcin levels, low calcium and high carbohydrate diet may share a relationship with MetS outcomes. The South Asian population has all the above-mentioned biochemical and metabolic alterations and it would be interesting to examine this in an immigrant Asian population residing in the USA. The investigators propose to examine 30 South Asian Indians between the ages of 30-50 years, using 30 resident Caucasian men as controls. Bone measures such as BMD and bone mineral content will be measured at radius, trochanter, hip and tibia and body composition including lean mass, fat mass, android fat and gynoid fat will be assessed using the Dual X ray energy absorptiometry (DXA). Biochemical measures including a complete metabolic panel, PTH, 25OHD, osteocalcin and other bone markers, and pro inflammatory cytokines will be measured in the serum. Investigators hypothesize that South Asian Indian men will have a lower BMD and higher MetS risk factors compared to age and BMI matched Caucasian men. Investigators further propose that common biochemical and metabolic alterations will underlie both low BMD and MetS outcomes in SAI population, but not in the Caucasian population. Identification of common determinants will help design a single future interventional trial that will target both MetS and bone health in the SA population

Specific Aim 1 To determine whether Bone Mineral Density (BMD) at weight-bearing and non weight-bearing sites is lower in age- and weight-matched SAI compared to white men.

It is hypothesized that SAI men will have lower BMD at weight-bearing sites compared to age and BMI-matched white men.

Specific Aim 2 To determine whether body composition influences Bone Mineral Density in SAI men.

研究设计

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

入排标准

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

入选标准

  • South Asian Indian and Caucasian males
  • 20 and 50 years of age
  • BMI range 23 - 35 kg/m2

排除标准

  • An individual is unwilling to sign the informed consent document.
  • A physician states that a participant is not able to participate in the study.
  • Individuals with the presence of any acute illness in the past month.
  • Individuals with preexisting chronic medical conditions such as diabetes (type I and II), cancer, other metabolic disorders.
  • Individuals who are using medications known to influence bone, blood glucose, lipids,and blood pressure.
  • Individuals who had a history of major diseases, such as cardiac, diabetes, renal, or evidence of cancer, in the past year.

结局指标

主要结局

Bone Mineral Density ( g/cm2)

时间窗: 1 day at baseline

Baseline differences in BMD in 2 groups

Total Body fat ( kg)

时间窗: 1 day at baseline

Using the total body scan from the DXA , fat mass will be assessed

Lean mass ( Kg)

时间窗: 1 day at baseline

Using the total body scan from the DXA , lean mass will be assessed

Visceral adipose tissue - VAT ( kg)

时间窗: 1 day at baseline

Using the total body scan from the DXA ,VAT mass will be assessed

次要结局

  • Blood pressure(1 day)
  • beta-C-terminal telopeptide (CTx) - ug/L(1 day)
  • Osteocalcin ( total)- ng/mL(1 day)
  • Interleukin-6 ( IL-6)- pg/mL(1 day at baseline)
  • Monocyte Chemoattractant protein-1 ( MCP-1)- ng//mL(1 day at baseline)
  • C- Reactive Protein ( CRP)-mg/L(1 day at baseline)
  • Adiponectin- ng/mL(1 day at baseline)
  • Lipid profile(1 day)
  • Parathyroid hormone- pg/mL(1 day)
  • 25 hydroxy vitamin D- ng/ML(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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