Role of Cardiometabolic Risk Factors in Childhood Bone Development

NCT02355717 | Unknown DMC

• 1 other identifier: 616274
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Bone mineral mass

  Measurement of bone quantity assessed by peripheral quantitative computed tomography

  Change from baseline bone mineral mass at 2 years

• Bone strength-strain index

  Measurement of bone quality assessed by peripheral quantitative computed tomography

  Change from baseline bone strength-strain index at 2 years

Secondary Outcomes (2)

• Serum N-terminal propeptide of type 1 procollagen (P1NP)

  Change from baseline P1NP at 2 years

• Serum C-terminal telopeptide of type 1 collagen (CTX)

  Change from baseline CTX at 2 years

Study Arms (1)

Prospective Cohort

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

Other: Observational Study

Interventions

Observational Study OTHER

Prospective Cohort

Eligibility Criteria

• Age: 9 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

400 children and adolescents aged 9 to 15 years

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Medical College of Georgia; Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 17991669 BACKGROUND

• 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.

  PMID: 20641032 BACKGROUND

• 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.

  PMID: 20449571 BACKGROUND

• 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.

  PMID: 21232765 BACKGROUND

• 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.

  PMID: 20458605 BACKGROUND

• 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.

  PMID: 21508147 BACKGROUND

• 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.

  PMID: 23296755 BACKGROUND

Related Links

• Faculty Directory Profile

MeSH Terms

Conditions

Obesity; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Osteoporosis; Diabetes Mellitus

Interventions

Observation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Norman K Pollock, Ph.D.

  Department of Medicine, Medical College of Georgia, Augusta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Norman K Pollock, Ph.D.

CONTACT

706-721-5424; npollock@augusta.edu

Celestine F Williams, M.S.

CONTACT

706-721-8553; cewilliams@augusta.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Medicine

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: February 4, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2021
• Study Completion: December 30, 2021
• Last Updated: November 20, 2019

Record last verified: 2019-11

Locations

US (1)