HealthyNCT02565823
The Effects of Exercise of Secreted Factors From Muscle and Adipose Tissue
A study testing Exercise bout in people with Healthy, run by Joslin Diabetes Center at 1 site in United States.
Trial summary
The purpose of this study is to find out whether exercise leads to changes in the blood that are produced by exercised muscles and if these changes produce new hormones that affect the body's regulation of sugar and body weight. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Exercise bout
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Mar 2016
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-35. Body mass index (BMI) must be ≥20 and ≤26 kg/m2. HbA1c values ≤5.7%
Who cannot join
- Age <18 and >35; HbA1c ≥ 5.7%; heart or lung disease; acute systemic infection accompanied by fever, body aches, or swollen lymph glands; BMI ≥ 26 kg/m2; current dieting or weight loss efforts; current pregnancy or breastfeeding; known history of HIV/AIDS; cancer; biochemical evidence of renal or hepatic dysfunction; renal or liver disease; demyelinating diseases such as multiple sclerosis or amyotrophic lateral sclerosis; recent blood donation; clinical history of stroke; hypertension (systolic > 140 mmHg or diastolic > 90 mmHg); type 1 or 2 diabetes; history of keloid formation inability to exercise at 50% of predicted heart rate (HR) reserve at baseline. Participants taking beta-blockers Participants who screen positive for The American Heart Association's contraindications to exercise testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Exercise-Induced Myokines and Adipokines
The purpose of this study is to find out whether exercise leads to changes in the blood that are produced by exercised muscles and if these changes produce new hormones that affect the body's regulation of sugar and body weight.
Read the detailed description
Recent work in the laboratory at the Joslin Diabetes Center and elsewhere has shown that when small animals exercise they improve their muscles and improve their blood sugar levels. Also, these animals show changes in their abdominal fat tissue, compared to animals that did not exercise. Our data suggest that factors released from exercised muscle and fat tissue from exercised mice also has a positive effect on other tissues in the same animal. Therefore, there could be new factors or hormones, which come from the trained animals' muscles or fat tissue and which exert a positive effect on the animals' blood sugar levels. Large studies with human volunteers have shown that exercise can improve blood sugar uptake into skeletal muscle and lower blood sugar levels, thereby preventing type 2 diabetes. The purpose if this study is to evaluate if a single exercise bout leads to changes in circulating factors in the blood. We plan to detect if there are hormones being produced in the body that have a beneficial effect elsewhere in the body.
- Conditions
- Healthy
- Being tested
- Exercise bout
- Keywords
- Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise boutOther
Participants will exercise for 45min at 75% of VO2peak
| Study group | Role | What they receive |
|---|---|---|
| Exercise intervention | Experimental | Subjects will undergo an acute bout of exercise for 45 mins at 75% of peak aerobic capacity Receives: Other: Exercise bout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in myokines/adipokine concentration
Measured: baseline, and 15, 45 and 1h:45 mins after exercise session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- Daiichi Sankyo
- Responsible party
- Principal investigator, Laurie Goodyear, Joslin Diabetes Center
- Investigators
- Laurie J. Goodyear, Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565823
- Sponsor's protocol ID
- CHS2015-11
- Status last verified
- Apr 2016
- First submitted
- 30 Sep 2015
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Exercise-Induced Myokines and Adipokines
- ClinicalTrials.gov ID
- NCT02565823
- Acronym / sponsor ID
- CHS2015-11
- Conditions
- Healthy
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- Daiichi Sankyo
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 Oct 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 purpose of this study is to find out whether exercise leads to changes in the blood that are produced by exercised muscles and if these changes produce new hormones that affect the body's regulation of sugar and body weight.
Detailed description
Recent work in the laboratory at the Joslin Diabetes Center and elsewhere has shown that when small animals exercise they improve their muscles and improve their blood sugar levels. Also, these animals show changes in their abdominal fat tissue, compared to animals that did not exercise. Our data suggest that factors released from exercised muscle and fat tissue from exercised mice also has a positive effect on other tissues in the same animal. Therefore, there could be new factors or hormones, which come from the trained animals' muscles or fat tissue and which exert a positive effect on the animals' blood sugar levels. Large studies with human volunteers have shown that exercise can improve blood sugar uptake into skeletal muscle and lower blood sugar levels, thereby preventing type 2 diabetes. The purpose if this study is to evaluate if a single exercise bout leads to changes in circulating factors in the blood. We plan to detect if there are hormones being produced in the body that have a beneficial effect elsewhere in the body.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention | Experimental | Other: Exercise boutSubjects will undergo an acute bout of exercise for 45 mins at 75% of peak aerobic capacity |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age between 18-35. Body mass index (BMI) must be ≥20 and ≤26 kg/m2. HbA1c values ≤5.7%
Key exclusion criteria (1 listed)
- Age <18 and >35; HbA1c ≥ 5.7%; heart or lung disease; acute systemic infection accompanied by fever, body aches, or swollen lymph glands; BMI ≥ 26 kg/m2; current dieting or weight loss efforts; current pregnancy or breastfeeding; known history of HIV/AIDS; cancer; biochemical evidence of renal or hepatic dysfunction; renal or liver disease; demyelinating diseases such as multiple sclerosis or amyotrophic lateral sclerosis; recent blood donation; clinical history of stroke; hypertension (systolic > 140 mmHg or diastolic > 90 mmHg); type 1 or 2 diabetes; history of keloid formation inability to exercise at 50% of predicted heart rate (HR) reserve at baseline. Participants taking beta-blockers Participants who screen positive for The American Heart Association's contraindications to exercise testing
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 |
|---|---|---|
| Exercise boutParticipants will exercise for 45min at 75% of VO2peak | Other | Exercise intervention |
Primary outcome
Changes in myokines/adipokine concentration
Time frame: baseline, and 15, 45 and 1h:45 mins after exercise session.
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 21 Apr 2016.
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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.
Laurie J. Goodyear principal investigator
Joslin Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise bout in people with Healthy, run by Joslin Diabetes Center 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 1 inclusion and 1 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 21 Apr 2016. 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?
Changes in myokines/adipokine concentration (time frame: baseline, and 15, 45 and 1h:45 mins after exercise session.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2016.