Musculoskeletal and Metabolic CrosstalkCOMBNCT02040727
Effect of Resistance Training on Musculoskeletal Endocrine Interactions
A study testing Resistance Training and No Resistance Training in people with Musculoskeletal and Metabolic Crosstalk, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This project will evaluate the impact of resistance training on the synthesis and release of hormones and growth factors from the musculoskeletal system and the extent to which the communicative capacity influences glucose homeostasis In turn, the contribution of glucose regulation on the musculoskeletal system will… Read more about this study
- Who is it for?
- Ages 7 to 12 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal and Metabolic Crosstalk
- What is being tested?
- Resistance Training and No Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Sep 2014
- Phase
- Interventional
- 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 7 to 12 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- overweight
- early pubertal boys (Tanner stage <3)
- ages 7-12 years
- self-identified as Non-Hispanic Black.
Who cannot join
- type 1 or 2 diabetes
- musculoskeletal disorders
- disturbances in glucose or lipid metabolism
- use of thyroid medication, diuretics, beta-blockers, or any medication that potentially could affect body composition, the lipid profile, insulin sensitivity, or blood pressure
- allergy to EMLA cream
- history of eating disorders, cancer, kidney disease, endocrinopathy, liver disease, heart disease, or thyroid disease
- medically determined not to be able to engage in resistance training
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Communications of Muscle and Bone
This project will evaluate the impact of resistance training on the synthesis and release of hormones and growth factors from the musculoskeletal system and the extent to which the communicative capacity influences glucose homeostasis In turn, the contribution of glucose regulation on the musculoskeletal system will also be evaluated. This small study will serve as a pilot/feasibility study to define a protocol for implementation of a resistance training intervention in the pediatric population. To establish feasibility, this study population is limited to overweight African American boys ages 7-11 years.
In light of well-established accolades of resistance training, historical recommendations for avoidance among the pediatric population have deterred implementation of resistance training interventions in young adolescents. However, contemporary data indicating a profound benefit of resistance training to the skeletal system in pre-adolescents has led to the Academy of Sports Medicine, as well as various other pediatric health interest groups, to support supervised programs incorporating resistance training in young children, emphasizing large muscle and core strengthening. To date, such trials have not been conducted in the pediatric population
Read the detailed description
Early adolescence (pre-puberty) is associated with many physiological changes with the intersection of metabolic pathways and body composition at the core. Lifestyle behaviors provide substantial influence and the rise of sedentary behavior particularly among this population can exert profound disruption. Metabolic dysfunction associated with limited activity and thus limited strain on the muscles and bones is associated with poor musculoskeletal health. Metabolic disturbance within the system during critical periods of development such as pre-puberty confers long-term health consequences.
Communication across systems is reliant upon various hormones which interact on the regulation of glucose homeostasis, bone metabolism, and muscle development. While it is well-established that bone and muscle growth are dependent upon fuel utilization, factors secreted by bone and muscle have been recently shown to play an interactive role in glucose homeostasis. Data derived primarily from animal models have demonstrated maintenance of physiological levels promote optimal growth and development, whereas these hormones appear to have adverse effects when levels are altered. While the data in animals is compelling, translation in humans has not been conducted.
Speculatively, impaired glucose homeostasis, much attributable to decreased strain on the musculoskeletal system, promotes impairments in physiological roles of these hormones. As a result, disordered development may be of consequence, such that the bones grow bigger yet have impaired quality, and delivery of fuel to muscle is compromised. Obesity-induced perturbations in metabolism and tissue partitioning may be an added stress to the system, impairing muscle function, power, performance and overall quality. Strategies that optimize the protective effects of the musculoskeletal system may be encompassed by forced stress on the system via resistance training, known to influence synthesis and release of hormones involved in fuel delivery and utilization by muscle and bone. The strategy proposed will target optimization of musculoskeletal health, promoting synthesis and release of musculoskeletal-derived signals providing protection on metabolic health at a critical period of development.
- Conditions
- Musculoskeletal and Metabolic Crosstalk
- Being tested
- Resistance Training, No Resistance Training
- Keywords
- Myokines, Osteokines, Glucose homeostasis, Puberty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingBehavioural
Supervised strength training 3 days per week for 24 weeks
No Resistance TrainingBehavioural
No supervised strength training throughout the study
| Study group | Role | What they receive |
|---|---|---|
| Non-Resistance Trained | Active comparator | No Participation in Resistance Training Receives: Behavioral: No Resistance Training |
| Resistance Trained | Experimental | Participation in Resistance Training Receives: Behavioral: Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting plasma FGF-23 concentration
Fibroblast Growth Factor-23
Measured: 0,8,12,16, 24 weeks
Fasting serum osteocalcin concentration
Measured: 0, 8, 12, 16, 24 weeks
Fasting serum insulin concentration
Measured: 0, 8, 12, 16, 24 weeks
Fasting serum glucose concentration
Measured: 0, 8, 12, 16, 24 weeks
Secondary outcomes (4)
Bone mineral content
by DXA
Measured: 0, 12, 24 weeks
Muscle strength
Measured: 0, 8, 12, 16, 24 weeks
Muscle density
by pQCT
Measured: 0, 12, 24 weeks
Bone stress-strain index
by pQCT
Measured: 0, 12, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startOct 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal and Metabolic CrosstalkStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lynae J. Hanks, PhD. RD, University of Alabama at Birmingham
- Investigators
- Orlando M Gutierrez, MD, MMSc, Study director, University of Alabama at BirminghamLynae J Hanks, PhD, RD, Principal investigator, University of Alabama at BirminghamKrista Casazza, PhD, RD, Study director, University of Alabama at BirminghamMarcas Bamman, PhD, Study director, University of Alabama at BirminghamAmbika Ashraf, MD, Study chair, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040727
- Sponsor's protocol ID
- COMB
- Acronym
- COMB
- Status last verified
- Apr 2015
- First submitted
- 10 Dec 2013
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hanks LJ, Gutierrez OM, Ashraf AP, Casazza K. Bone Mineral Content as a Driver of Energy Expenditure in Prepubertal and Early Pubertal Boys. J Pediatr. 2015 Jun;166(6):1397-403. doi: 10.1016/j.jpeds.2015.02.054. Epub 2015 Apr 1.
PubMed 25841541
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communications of Muscle and Bone
- ClinicalTrials.gov ID
- NCT02040727
- Acronym / sponsor ID
- COMB / COMB
- Conditions
- Musculoskeletal and Metabolic Crosstalk
- Keywords
- Myokines, Osteokines, Glucose homeostasis, Puberty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 20 Jan 2014 (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.
This project will evaluate the impact of resistance training on the synthesis and release of hormones and growth factors from the musculoskeletal system and the extent to which the communicative capacity influences glucose homeostasis In turn, the contribution of glucose regulation on the musculoskeletal system will also be evaluated. This small study will serve as a pilot/feasibility study to define a protocol for implementation of a resistance training intervention in the pediatric population. To establish feasibility, this study population is limited to overweight African American boys ages 7-11 years.
In light of well-established accolades of resistance training, historical recommendations for avoidance among the pediatric population have deterred implementation of resistance training interventions in young adolescents. However, contemporary data indicating a profound benefit of resistance training to the skeletal system in pre-adolescents has led to the Academy of Sports Medicine, as well as various other pediatric health interest groups, to support supervised programs incorporating resistance training in young children, emphasizing large muscle and core strengthening. To date, such trials have not been conducted in the pediatric population
Detailed description
Early adolescence (pre-puberty) is associated with many physiological changes with the intersection of metabolic pathways and body composition at the core. Lifestyle behaviors provide substantial influence and the rise of sedentary behavior particularly among this population can exert profound disruption. Metabolic dysfunction associated with limited activity and thus limited strain on the muscles and bones is associated with poor musculoskeletal health. Metabolic disturbance within the system during critical periods of development such as pre-puberty confers long-term health consequences.
Communication across systems is reliant upon various hormones which interact on the regulation of glucose homeostasis, bone metabolism, and muscle development. While it is well-established that bone and muscle growth are dependent upon fuel utilization, factors secreted by bone and muscle have been recently shown to play an interactive role in glucose homeostasis. Data derived primarily from animal models have demonstrated maintenance of physiological levels promote optimal growth and development, whereas these hormones appear to have adverse effects when levels are altered. While the data in animals is compelling, translation in humans has not been conducted.
Speculatively, impaired glucose homeostasis, much attributable to decreased strain on the musculoskeletal system, promotes impairments in physiological roles of these hormones. As a result, disordered development may be of consequence, such that the bones grow bigger yet have impaired quality, and delivery of fuel to muscle is compromised. Obesity-induced perturbations in metabolism and tissue partitioning may be an added stress to the system, impairing muscle function, power, performance and overall quality. Strategies that optimize the protective effects of the musculoskeletal system may be encompassed by forced stress on the system via resistance training, known to influence synthesis and release of hormones involved in fuel delivery and utilization by muscle and bone. The strategy proposed will target optimization of musculoskeletal health, promoting synthesis and release of musculoskeletal-derived signals providing protection on metabolic health at a critical period of development.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Resistance Trained | Active comparator | Behavioral: No Resistance TrainingNo Participation in Resistance Training |
| Resistance Trained | Experimental | Behavioral: Resistance TrainingParticipation in Resistance Training |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- overweight
- early pubertal boys (Tanner stage <3)
- ages 7-12 years
- self-identified as Non-Hispanic Black.
Key exclusion criteria (7 listed)
- type 1 or 2 diabetes
- musculoskeletal disorders
- disturbances in glucose or lipid metabolism
- use of thyroid medication, diuretics, beta-blockers, or any medication that potentially could affect body composition, the lipid profile, insulin sensitivity, or blood pressure
- allergy to EMLA cream
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 |
|---|---|---|
| Resistance TrainingSupervised strength training 3 days per week for 24 weeks | Behavioural | Resistance Trained |
| No Resistance TrainingNo supervised strength training throughout the study | Behavioural | Non-Resistance Trained |
Primary outcome
Fasting plasma FGF-23 concentration
Time frame: 0,8,12,16, 24 weeks
Fibroblast Growth Factor-23
Fasting serum osteocalcin concentration
Time frame: 0, 8, 12, 16, 24 weeks
Fasting serum insulin concentration
Time frame: 0, 8, 12, 16, 24 weeks
Fasting serum glucose concentration
Time frame: 0, 8, 12, 16, 24 weeks
4 secondary outcomes
Bone mineral content
Time frame: 0, 12, 24 weeks
Muscle strength
Time frame: 0, 8, 12, 16, 24 weeks
Muscle density
Time frame: 0, 12, 24 weeks
Bone stress-strain index
Time frame: 0, 12, 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2015.
- Derived from this study: PubMed 25841541Hanks LJ, Gutierrez OM, Ashraf AP, Casazza K. Bone Mineral Content as a Driver of Energy Expenditure in Prepubertal and Early Pubertal Boys. J Pediatr. 2015 Jun;166(6):1397-403. doi: 10.1016/j.jpeds.2015.02.054. Epub 2015 Apr 1.
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.
Orlando M Gutierrez, MD, MMSc study director
University of Alabama at Birmingham
Lynae J Hanks, PhD, RD principal investigator
University of Alabama at Birmingham
Krista Casazza, PhD, RD study director
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training and No Resistance Training in people with Musculoskeletal and Metabolic Crosstalk, run by University of Alabama at Birmingham 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 17 Apr 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting plasma FGF-23 concentration (time frame: 0,8,12,16, 24 weeks). The study lists 4 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 NCT02040727, which also lists 1 linked publication.
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 17 Apr 2015.