Role of Cardiometabolic Risk Factors in Childhood Bone Development

NCT ID: NCT02355717

Last Updated: 2019-11-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2021-12-30

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.

Detailed Description

The overall goal of this study is to clarify the relationship of adiposity with bone development during adolescence, and to explicate the mechanisms that regulate the effect of excess adiposity on bone. In this effort, we will conduct a 2-year longitudinal study in 400 children and adolescents aged 9-15 years. Using the peak adolescent growth period as a model for probing determinants of bone health may allow for a clearer picture of the processes that regulate bone development, as these processes are highly active at this growth stage. Unlike other studies with surrogates for adiposity, we plan to measure total and central adiposity directly, using dual energy X-ray absorptiometry (DXA) and magnetic resonance imaging. Both bone quantity and bone quality, the two principal determinants of bone strength, will be assessed by peripheral quantitative computed tomography (pQCT) at weight-bearing (tibia) and non-weight-bearing (radius) skeletal sites. Peripheral QCT provides 3-dimensional bone measurements that are not confounded by changes in bone size, a significant confounder of most past studies, which have relied on 2-dimensional bone imaging techniques. To identify mechanistic factors, which may explain the effect of adiposity on bone development, we will measure arterial stiffness, endothelial function, and fasting levels of glucose, insulin, lipids, and C-reactive protein (CRP) to assess how vascular dysfunction, insulin resistance, abnormal lipids, and inflammation are related to bone modeling activity, as measured by serum markers of bone formation and resorption. All measurements will be assessed at baseline and after 1 and 2 years of follow-up.

Conditions

Obesity; Cardiovascular Disease; Type 2 Diabetes; Osteoporosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Prospective Cohort

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

Observational Study

Intervention Type: OTHER

Interventions

Observational Study

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Augusta University

OTHER

Sponsor Role: lead

Responsible Party

Norman Pollock

Associate Professor, Department of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Norman K Pollock, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, Medical College of Georgia, Augusta University

Locations

Medical College of Georgia; Augusta University

Augusta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Norman K Pollock, Ph.D.

Role: CONTACT

npollock@augusta.edu

706-721-5424

Celestine F Williams, M.S.

Role: CONTACT

cewilliams@augusta.edu

706-721-8553

Facility Contacts

Norman K Pollock, Ph.D.

Role: primary

npollock@augusta.edu

706-721-5424

References

Pollock NK, Laing EM, Baile CA, Hamrick MW, Hall DB, Lewis RD. Is adiposity advantageous for bone strength? A peripheral quantitative computed tomography study in late adolescent females. Am J Clin Nutr. 2007 Nov;86(5):1530-8. doi: 10.1093/ajcn/86.5.1530.

Reference Type: BACKGROUND

PMID: 17991669 (View on PubMed)

Pollock NK, Bernard PJ, Wenger K, Misra S, Gower BA, Allison JD, Zhu H, Davis CL. Lower bone mass in prepubertal overweight children with prediabetes. J Bone Miner Res. 2010 Dec;25(12):2760-9. doi: 10.1002/jbmr.184. Epub 2010 Jul 16.

Reference Type: BACKGROUND

PMID: 20641032 (View on PubMed)

Pollock NK, Laing EM, Hamrick MW, Baile CA, Hall DB, Lewis RD. Bone and fat relationships in postadolescent black females: a pQCT study. Osteoporos Int. 2011 Feb;22(2):655-65. doi: 10.1007/s00198-010-1266-6. Epub 2010 May 7.

Reference Type: BACKGROUND

PMID: 20449571 (View on PubMed)

Pollock NK, Bernard PJ, Gutin B, Davis CL, Zhu H, Dong Y. Adolescent obesity, bone mass, and cardiometabolic risk factors. J Pediatr. 2011 May;158(5):727-34. doi: 10.1016/j.jpeds.2010.11.052. Epub 2011 Jan 13.

Reference Type: BACKGROUND

PMID: 21232765 (View on PubMed)

Pollock NK, Laing EM, Taylor RG, Baile CA, Hamrick MW, Hall DB, Lewis RD. Comparisons of trabecular and cortical bone in late adolescent black and white females. J Bone Miner Metab. 2011 Jan;29(1):44-53. doi: 10.1007/s00774-010-0186-z. Epub 2010 May 11.

Reference Type: BACKGROUND

PMID: 20458605 (View on PubMed)

Pollock NK, Bernard PJ, Gower BA, Gundberg CM, Wenger K, Misra S, Bassali RW, Davis CL. Lower uncarboxylated osteocalcin concentrations in children with prediabetes is associated with beta-cell function. J Clin Endocrinol Metab. 2011 Jul;96(7):E1092-9. doi: 10.1210/jc.2010-2731. Epub 2011 Apr 20.

Reference Type: BACKGROUND

PMID: 21508147 (View on PubMed)

Laing EM, Tripp RA, Pollock NK, Baile CA, Della-Fera MA, Rayalam S, Tompkins SM, Keys DA, Lewis RD. Adenovirus 36, adiposity, and bone strength in late-adolescent females. J Bone Miner Res. 2013 Mar;28(3):489-96. doi: 10.1002/jbmr.1776.

Reference Type: BACKGROUND

PMID: 23296755 (View on PubMed)

Related Links

https://www.augusta.edu/faculty/directory/view.php?id=NPOLLOCK

Faculty Directory Profile

Other Identifiers

616274

Identifier Type: -

Identifier Source: org_study_id