NCT03600675

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2015

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2021

Completed
Last Updated

September 27, 2021

Status Verified

September 1, 2021

Enrollment Period

5 years

First QC Date

March 14, 2018

Last Update Submit

September 23, 2021

Conditions

Osteoporosis

Keywords

Body compositionAbdominal fatInflammatory cytokinesBone markersBone mineral density

Outcome Measures

Primary Outcomes (4)

  • Bone Mineral Density ( g/cm2)

    Baseline differences in BMD in 2 groups

    1 day at baseline

  • Total Body fat ( kg)

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

    1 day at baseline

  • Lean mass ( Kg)

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

    1 day at baseline

  • Visceral adipose tissue - VAT ( kg)

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

    1 day at baseline

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

South Asian Indians

No intervention will be applied for any group

Other: No intervention element, observational study.

Caucasians

No intervention will be applied for any group

Other: No intervention element, observational study.

Interventions

No intervention element, observational study.OTHER

No intervention will be applied to any group. It is an observational study and all measurements are collected during one visit.

Also known as: Observational Study
CaucasiansSouth Asian Indians

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel University Nutrition Sciences Research Lab

Philadelphia, Pennsylvania, 19102, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood and urine

MeSH Terms

Conditions

Osteoporosis

Interventions

Observation

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Deeptha Sukumar, PhD

    Drexel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2018

First Posted

July 26, 2018

Study Start

May 8, 2015

Primary Completion

May 8, 2020

Study Completion

May 8, 2021

Last Updated

September 27, 2021

Record last verified: 2021-09

Locations

US(1)