ObesityNCT02355717
Role of Cardiometabolic Risk Factors in Childhood Bone Development
An observational study of Obesity and Cardiovascular Disease, run by Augusta University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Cardiovascular Disease, Type 2 Diabetes
- What is being tested?
- Observational Study
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 400 children and adolescents aged 9 to 15 years
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Medical College of Georgia; Augusta University
Augusta, Georgia, 30912
Norman K Pollock, Ph.D., 706-721-5424, npollock@augusta.edu
About this study
Official title: Role of Cardiometabolic Risk Factors in Childhood Bone Development (Healthy Heart 'N' Bones Study)
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.
Read the 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
- Being tested
- Observational Study
- Keywords
- children, bone, Simple obesity, cardiovascular disease, osteoporosis, diabetes
- Medical subject headings
- Obesity, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Osteoporosis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational StudyOther
| Study group | Role | What they receive |
|---|---|---|
| Prospective Cohort | 400 otherwise healthy children and adolescents aged 9-15 years will be recruited to participate in a 2-year longitudinal study. Receives: Other: Observational Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral mass
Measurement of bone quantity assessed by peripheral quantitative computed tomography
Measured: Change from baseline bone mineral mass at 2 years
Bone strength-strain index
Measurement of bone quality assessed by peripheral quantitative computed tomography
Measured: Change from baseline bone strength-strain index at 2 years
Secondary outcomes (2)
Serum N-terminal propeptide of type 1 procollagen (P1NP)
Marker of bone formation as measured in serum
Measured: Change from baseline P1NP at 2 years
Serum C-terminal telopeptide of type 1 collagen (CTX)
Marker of bone resorption as measured in serum
Measured: Change from baseline CTX at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startDec 2014
- Primary completion1 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norman Pollock, Augusta University
- Investigators
- Norman K Pollock, Ph.D., Principal investigator, Department of Medicine, Medical College of Georgia, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355717
- Sponsor's protocol ID
- 616274
- Status last verified
- Nov 2019
- First submitted
- 22 Jan 2015
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17991669Pollock 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.
PubMed 20641032Pollock 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.
PubMed 20449571Pollock 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.
PubMed 21232765Pollock 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.
PubMed 20458605Pollock 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.
PubMed 21508147Laing 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.
PubMed 23296755
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Cardiometabolic Risk Factors in Childhood Bone Development (Healthy Heart 'N' Bones Study)
- ClinicalTrials.gov ID
- NCT02355717
- Acronym / sponsor ID
- 616274
- Conditions
- Obesity, Cardiovascular Disease, Type 2 Diabetes, Osteoporosis
- Keywords
- children, bone, Simple obesity, cardiovascular disease, osteoporosis, diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 4 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort | – | Other: Observational Study400 otherwise healthy children and adolescents aged 9-15 years will be recruited to participate in a 2-year longitudinal study. |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 400 children and adolescents aged 9 to 15 years
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational Study | Other | Prospective Cohort |
Primary outcome
Bone mineral mass
Time frame: Change from baseline bone mineral mass at 2 years
Measurement of bone quantity assessed by peripheral quantitative computed tomography
Bone strength-strain index
Time frame: Change from baseline bone strength-strain index at 2 years
Measurement of bone quality assessed by peripheral quantitative computed tomography
2 secondary outcomes
Serum N-terminal propeptide of type 1 procollagen (P1NP)
Time frame: Change from baseline P1NP at 2 years
Serum C-terminal telopeptide of type 1 collagen (CTX)
Time frame: Change from baseline CTX at 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Background: PubMed 17991669Pollock 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.
- Background: PubMed 20641032Pollock 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.
- Background: PubMed 20449571Pollock 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.
- Background: PubMed 21232765Pollock 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.
- Background: PubMed 20458605Pollock 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.
- Background: PubMed 21508147Pollock 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.
- Background: PubMed 23296755Laing 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.
- Faculty Directory ProfileLink provided by the sponsor.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norman K Pollock, Ph.D. principal investigator
Department of Medicine, Medical College of Georgia, Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Cardiovascular Disease, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Norman K Pollock, Ph.D. (706-721-5424, npollock@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral mass (time frame: Change from baseline bone mineral mass at 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02355717, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2019.