Recruiting

Observational Study

Sponsor:

Augusta University

Code:

NCT02355717

Conditions

Obesity

Cardiovascular Disease

Type 2 Diabetes

Osteoporosis

Eligibility Criteria

Sex: All

Age: 9 - 15

Healthy Volunteers: Accepted

Interventions

Observational Study

Study Details

Brief summary:

The proposed research brings together complementary expertise to systematically elucidate the longitudinal effects of (1) total and regional body fat and (2) the metabolic impairment that accompanies obesity on bone development during growth. The contribution of this research will be significant because it will provide a solid foundation for understanding the influence of fat (total and regional distribution) on overall bone strength, and whether insulin resistance, beta-cell dysfunction, abnormal lipids, and inflammation could be underpinning factors in the fat-bone strength relationship via effects on bone modeling activity. This knowledge will provide critical information needed to maximize potential therapeutic interventions to counter the linked risks of obesity and osteoporosis, both major public health concerns.

Conditions

Obesity

Cardiovascular Disease

Type 2 Diabetes

Osteoporosis

Study ID

NCT02355717

Start date

Dec, 2014

Status verified date

Nov, 2019

Completion date

Dec 30, 2021

Anticipated

Primary completion date

Dec 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9 - 15

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Otherwise healthy children and adolescents between 9 and 15 years old
2. Subject and parent/guardian understands the study protocol and agrees to comply with it
3. Informed Consent Form signed by the parent/guardian and assent signed by the subject

Exclusion Criteria:

1. Subjects with (a history of) metabolic or gastrointestinal diseases including hepatic disorders
2. Subjects presenting chronic degenerative and/or inflammatory diseases
3. Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (salicylates, antibiotics)
4. Subjects receiving corticosteroid treatment
5. Subjects using oral anticoagulants
6. Subjects who have participated in a clinical study more recently than one month before the current study

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Prospective Cohort

400 otherwise healthy children and adolescents aged 9-15 years will be recruited to participate in a 2-year longitudinal study.

Interventions

Observational Study

Primary outcome measure

  • Bone mineral mass [ Time Frame: Change from baseline bone mineral mass at 2 years ]
  • Bone strength-strain index [ Time Frame: Change from baseline bone strength-strain index at 2 years ]

Central Contacts and Locations

Central contacts

Norman K Pollock, Ph.D.

706-721-5424npollock@augusta.edu

Celestine F Williams, M.S.

706-721-8553cewilliams@augusta.edu

Locations

Medical College of Georgia; Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Norman K Pollock, Ph.D.

706-721-5424npollock@augusta.edu

More Information

Sponsor

Augusta University

Last update posted

Nov 20, 2019

Last verified

Nov, 2019

Keywords

  • children, bone
  • Simple obesity
  • cardiovascular disease
  • osteoporosis
  • diabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-03. This information was provided to ClinicalTrials.gov by Augusta University on 2019-11-20.