Drexel University Nutrition Sciences Research Lab
Philadelphia, Pennsylvania, 19102, United States
NCT Number: NCT03600675
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
Looking for future studies?
Notify Me20 year–50 year
Male
Observational
Philadelphia, Pennsylvania, 19102, United States
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.
It is hypothesized that greater abdominal adiposity, specifically visceral fat, influences BMD in SAI men compared to age- and BMI-matched white men.
Specific Aim 3 To examine the hormonal, inflammatory, and dietary determinants of Bone Mineral Density and MetS in SAI compared to white men.
It is hypothesized that the hormonal, inflammatory, and dietary determinants of both MetS and low BMD will be similar in the SAI men but not in the white men.
This study will involve one single visit. The following will be conducted during this visit:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No intervention will be applied to any group. It is an observational study and all measurements are collected during one visit.
Other names: Observational Study
Time frame: 1 day at baseline
Baseline differences in BMD in 2 groups
Time frame: 1 day at baseline
Using the total body scan from the DXA , fat mass will be assessed
Time frame: 1 day at baseline
Using the total body scan from the DXA , lean mass will be assessed
Time frame: 1 day at baseline
Using the total body scan from the DXA ,VAT mass will be assessed
Time frame: 1 day at baseline
Serum levels will be assayed
Time frame: 1 day at baseline
Serum levels will be assayed
Time frame: 1 day at baseline
Serum levels will be assayed
Time frame: 1 day at baseline
Serum levels will be assayed
Time frame: 1 day
Serum levels of HDL, LDL, Total cholesterol and triglycerides will be assayed ( mg/dL)
Time frame: 1 day
Time frame: 1 day
Serum levels will be assayed
Time frame: 1 day
Serum levels will be assayed
Time frame: 1 day
Serum levels will be assayed
Time frame: 1 day
Serum levels will be assayed
Drexel University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07725081
Attitudes, Behavior
Afyonkarahisar, Turkey (Türkiye)
View Trial DetailsNCT05541432
Behavior, Bone Diseases
Waterloo, Ontario, Canada
View Trial DetailsNCT03924414
Atypical Parkinsonism, Autonomic Nervous System Diseases
Scottsdale, Arizona, United States
View Trial DetailsNCT02924545
Bone Diseases, Bone Diseases, Metabolic
Nîmes, France
View Trial Details