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

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ClinicalTrials.gov Identifier: NCT03600675
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Drexel University

Brief 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. 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

Condition or disease Intervention/treatment
Osteoporosis Other: No intervention element, observational study.

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Determinants of Bone Mineral Density and Metabolic Syndrome in South Asian Indian Men
Actual Study Start Date : May 8, 2015
Estimated Primary Completion Date : May 8, 2020
Estimated Study Completion Date : May 8, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
South Asian Indians
No intervention will be applied for any group
Other: No intervention element, observational study.
No intervention will be applied to any group. It is an observational study and all measurements are collected during one visit.
Other Name: Observational Study

Caucasians
No intervention will be applied for any group
Other: No intervention element, observational study.
No intervention will be applied to any group. It is an observational study and all measurements are collected during one visit.
Other Name: Observational Study




Primary Outcome Measures :
  1. Bone Mineral Density ( g/cm2) [ Time Frame: 1 day at baseline ]
    Baseline differences in BMD in 2 groups

  2. Total Body fat ( kg) [ Time Frame: 1 day at baseline ]
    Using the total body scan from the DXA , fat mass will be assessed

  3. Lean mass ( Kg) [ Time Frame: 1 day at baseline ]
    Using the total body scan from the DXA , lean mass will be assessed

  4. Visceral adipose tissue - VAT ( kg) [ Time Frame: 1 day at baseline ]
    Using the total body scan from the DXA ,VAT mass will be assessed


Secondary Outcome Measures :
  1. Interleukin-6 ( IL-6)- pg/mL [ Time Frame: 1 day at baseline ]
    Serum levels will be assayed

  2. Monocyte Chemoattractant protein-1 ( MCP-1)- ng//mL [ Time Frame: 1 day at baseline ]
    Serum levels will be assayed

  3. C- Reactive Protein ( CRP)-mg/L [ Time Frame: 1 day at baseline ]
    Serum levels will be assayed

  4. Adiponectin- ng/mL [ Time Frame: 1 day at baseline ]
    Serum levels will be assayed

  5. Lipid profile [ Time Frame: 1 day ]
    Serum levels of HDL, LDL, Total cholesterol and triglycerides will be assayed ( mg/dL)

  6. Blood pressure [ Time Frame: 1 day ]
  7. beta-C-terminal telopeptide (CTx) - ug/L [ Time Frame: 1 day ]
    Serum levels will be assayed

  8. Parathyroid hormone- pg/mL [ Time Frame: 1 day ]
    Serum levels will be assayed

  9. 25 hydroxy vitamin D- ng/ML [ Time Frame: 1 day ]
    Serum levels will be assayed

  10. Osteocalcin ( total)- ng/mL [ Time Frame: 1 day ]
    Serum levels will be assayed


Biospecimen Retention:   Samples With DNA
blood and urine


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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03600675


Contacts
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Contact: Deeptha Sukumar, PhD 267-359-5854 deeptha.sukumar@drexel.edu
Contact: Arun Ramakrishnan, PhD ar88@drexel.edu

Locations
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United States, Pennsylvania
Drexel University Nutrition Sciences Research Lab Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Deeptha Sukumar, PhD    267-359-5854    deeptha.sukumar@drexel.edu   
Sponsors and Collaborators
Drexel University
Investigators
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Principal Investigator: Deeptha Sukumar, PhD Drexel University

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Responsible Party: Drexel University
ClinicalTrials.gov Identifier: NCT03600675     History of Changes
Other Study ID Numbers: 1604004460R001
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Drexel University:
Body composition
Abdominal fat
Inflammatory cytokines
Bone markers
Bone mineral density

Additional relevant MeSH terms:
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Metabolic Syndrome
Osteoporosis
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases