OsteoporosisNCT03600675
Determinants of Bone Mineral Density and Metabolic Syndrome in South Asian Indian Men
An observational study of Osteoporosis, run by Drexel University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2015to 8 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: South Asians Indians are defined as those who can trace their ancestry to Bangladesh, Bhutan, India, the Maldives, Nepal, Pakistan, and Sri Lanka. Caucasians are defined as non-Hispanic who do not belong to any other ethnic group.
Who may be able to join
- South Asian Indian and Caucasian males
- 20 and 50 years of age
- BMI range 23 - 35 kg/m2
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Drexel University Nutrition Sciences Research Lab
Philadelphia, Pennsylvania, 19102
About this study
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
Read the detailed description
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:
- This visit will last for about 2 hours
- Blood draw- Four 5 ml tubes of blood will be collected via venipuncture
- Spot urine sample collection
- Measurement of height, weight, blood pressure, waist circumference
- Completion of study questionnaires
- DXA scan
- Conditions
- Osteoporosis
- Being tested
- No intervention element, observational study.
- Keywords
- Body composition, Abdominal fat, Inflammatory cytokines, Bone markers, Bone mineral density
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention element, observational study.Other
Also called Observational Study
No intervention will be applied to any group. It is an observational study and all measurements are collected during one visit.
| Study group | Role | What they receive |
|---|---|---|
| South Asian Indians | No intervention will be applied for any group Receives: Other: No intervention element, observational study. | |
| Caucasians | No intervention will be applied for any group Receives: Other: No intervention element, observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density ( g/cm2)
Baseline differences in BMD in 2 groups
Measured: 1 day at baseline
Total Body fat ( kg)
Using the total body scan from the DXA , fat mass will be assessed
Measured: 1 day at baseline
Lean mass ( Kg)
Using the total body scan from the DXA , lean mass will be assessed
Measured: 1 day at baseline
Visceral adipose tissue - VAT ( kg)
Using the total body scan from the DXA ,VAT mass will be assessed
Measured: 1 day at baseline
Secondary outcomes (10)
Interleukin-6 ( IL-6)- pg/mL
Serum levels will be assayed
Measured: 1 day at baseline
Monocyte Chemoattractant protein-1 ( MCP-1)- ng//mL
Serum levels will be assayed
Measured: 1 day at baseline
C- Reactive Protein ( CRP)-mg/L
Serum levels will be assayed
Measured: 1 day at baseline
Adiponectin- ng/mL
Serum levels will be assayed
Measured: 1 day at baseline
Lipid profile
Serum levels of HDL, LDL, Total cholesterol and triglycerides will be assayed ( mg/dL)
Measured: 1 day
Blood pressure
Measured: 1 day
beta-C-terminal telopeptide (CTx) - ug/L
Serum levels will be assayed
Measured: 1 day
Parathyroid hormone- pg/mL
Serum levels will be assayed
Measured: 1 day
25 hydroxy vitamin D- ng/ML
Serum levels will be assayed
Measured: 1 day
Osteocalcin ( total)- ng/mL
Serum levels will be assayed
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start8 May 2015
- Primary completion8 May 2020
- Study completion8 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deeptha Sukumar, PhD, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600675
- Sponsor's protocol ID
- 1604004460R001
- Status last verified
- Sep 2021
- First submitted
- 14 Mar 2018
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Bone Mineral Density and Metabolic Syndrome in South Asian Indian Men
- ClinicalTrials.gov ID
- NCT03600675
- Acronym / sponsor ID
- 1604004460R001
- Conditions
- Osteoporosis
- Keywords
- Body composition, Abdominal fat, Inflammatory cytokines, Bone markers, Bone mineral density
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- 8 May 2015 (actual)
- Primary completion
- 8 May 2020 (actual)
- Study completion
- 8 May 2021 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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:
- This visit will last for about 2 hours
- Blood draw- Four 5 ml tubes of blood will be collected via venipuncture
- Spot urine sample collection
- Measurement of height, weight, blood pressure, waist circumference
- Completion of study questionnaires
- DXA scan
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| South Asian Indians | – | Other: No intervention element, observational study.No intervention will be applied for any group |
| Caucasians | – | Other: No intervention element, observational study.No intervention will be applied for any group |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- South Asians Indians are defined as those who can trace their ancestry to Bangladesh, Bhutan, India, the Maldives, Nepal, Pakistan, and Sri Lanka. Caucasians are defined as non-Hispanic who do not belong to any other ethnic group.
Key inclusion criteria (3 listed)
- South Asian Indian and Caucasian males
- 20 and 50 years of age
- BMI range 23 - 35 kg/m2
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention element, observational study.Also: Observational StudyNo intervention will be applied to any group. It is an observational study and all measurements are collected during one visit. | Other | Caucasians, South Asian Indians |
Primary outcome
Bone Mineral Density ( g/cm2)
Time frame: 1 day at baseline
Baseline differences in BMD in 2 groups
Total Body fat ( kg)
Time frame: 1 day at baseline
Using the total body scan from the DXA , fat mass will be assessed
Lean mass ( Kg)
Time frame: 1 day at baseline
Using the total body scan from the DXA , lean mass will be assessed
Visceral adipose tissue - VAT ( kg)
Time frame: 1 day at baseline
Using the total body scan from the DXA ,VAT mass will be assessed
10 secondary outcomes
Interleukin-6 ( IL-6)- pg/mL
Time frame: 1 day at baseline
Monocyte Chemoattractant protein-1 ( MCP-1)- ng//mL
Time frame: 1 day at baseline
C- Reactive Protein ( CRP)-mg/L
Time frame: 1 day at baseline
Adiponectin- ng/mL
Time frame: 1 day at baseline
Lipid profile
Time frame: 1 day
Blood pressure
Time frame: 1 day
beta-C-terminal telopeptide (CTx) - ug/L
Time frame: 1 day
Parathyroid hormone- pg/mL
Time frame: 1 day
25 hydroxy vitamin D- ng/ML
Time frame: 1 day
Osteocalcin ( total)- ng/mL
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deeptha Sukumar, PhD principal investigator
Drexel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Drexel University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Mineral Density ( g/cm2) (time frame: 1 day at baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.