Metabolic SyndromeNCT01872273
Blood Cell Response to Exercise
An observational study of Metabolic Syndrome, run by USDA Grand Forks Human Nutrition Research Center.
Trial summary
Moderate exercise is recommended to improve cardiovascular health in obese and overweight people particularly with metabolic syndrome (MetS) that have hypertension, elevated fasting blood sugar, and elevated blood lipids. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Moderate Physical Exercise
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Jun 2016
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Obese adults with Metabolic Syndrome
Who may be able to join
- 30-60 years old
- BMI >/=26 and <40 kg/m2
- not planning to or currently attempting to gain or lose weight
- low reported omega-3 fatty acid intake per Omega-3 Checklist
- Metabolic Syndrome as define 3/5 of the following:Waist circumference: men > 102 cm women > 88 cm, triglycerides > 150 mg/dL, HDL cholesterol: men < 40 mg/dL women < 50 mg/dL,Blood pressure >130/>85 mmHg,Fasting glucose > 100 mg/dL (Hypertensive subjects are eligible if taking thiazide diuretics NOT ACE inhibitors beta blockers)
Who cannot join
- smoke or use tobacco or nicotine in any form (including pills and patches)
- take any medication that makes you unable to exercise
- have established cardiovascular, pulmonary, and/or metabolic disease such as diabetes
- have uncontrolled hypertension
- have alcohol, anabolic steroid, or other substance abuse issues
- consume more than 3 alcoholic drinks/week
Show all 15Show fewer
- have joint or muscle injuries that affects your ability to exercise
- have cancer (other than skin cancer or carcinoma in situ of the cervix
- pregnant or lactating
- currently exercise regularly
- taking non-steroidal anti-inflammatory medications (aspirin, Aleve, Advil, ibuprofen, naproxen
- take lipid modifying medications such as statins (Lipitor, Zocor)
- take medications for blood glucose such as insulin or metformin
- take medications that affect platelet functions (Plavix)
- taking omega-3 supplements (fish or flax oil)
About this study
Moderate exercise is recommended to improve cardiovascular health in obese and overweight people particularly with metabolic syndrome (MetS) that have hypertension, elevated fasting blood sugar, and elevated blood lipids. This study is being done to determine how platelets respond when a person performs an initial period of moderate exercise.
- Conditions
- Metabolic Syndrome
- Being tested
- Moderate Physical Exercise
- Keywords
- Metabolic Syndrome, Obese, Overweight, Hypertension, Hyperlipidemia, Glucose Intolerant, High blood sugar, Exercise in obesity, Platelets
- Medical subject headings
- Metabolic Syndrome, Obesity, Overweight, Hypertension, Hyperlipidemias, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate Physical ExerciseOther
This intervention is comprised of two separate visits at least one week apart. The purpose of visit 1 is to determine the cycle ergometer workload that produces a moderate exercise intensity of 60% heart rate reserve to be used on visit 2. The purpose of visit 2 is to determine changes in platelet reactivity in response to moderate exercise.
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Reactivity
We hypothesize that moderate physical exercise will increase platelet reactivity in sedentary individuals with metabolic syndrome. Platelet reactivity will be measured by flow cytometry using anti-CD61 antibodies as a marker for platelets and anti-CD62 (P-selectin) as a marker of platelet activation. This will be measured at baseline, post-intervention and time points post-baseline in each subject.
Measured: Baseline, post-intervention (24 hours), & time points during the exercise phase: prior to exercise (-25 min, -10 min, - 1 min), 10 minutes into the routine, at completion (25 minutes), and 20 & 60 minutes following completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Project never funded. No subjects were recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Matthew Picklo, PhD, Principal investigator, USDA Grand Forks Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872273
- Sponsor's protocol ID
- GFHNRC026
- Status last verified
- Jan 2022
- First submitted
- 1 May 2013
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Cell Response to Exercise
- ClinicalTrials.gov ID
- NCT01872273
- Acronym / sponsor ID
- GFHNRC026
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic Syndrome, Obese, Overweight, Hypertension, Hyperlipidemia, Glucose Intolerant, High blood sugar, Exercise in obesity
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Project never funded. No subjects were recruited.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- Feb 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 7 Jun 2013 (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.
Moderate exercise is recommended to improve cardiovascular health in obese and overweight people particularly with metabolic syndrome (MetS) that have hypertension, elevated fasting blood sugar, and elevated blood lipids. This study is being done to determine how platelets respond when a person performs an initial period of moderate exercise.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Obese adults with Metabolic Syndrome
Key inclusion criteria (5 listed)
- 30-60 years old
- BMI >/=26 and <40 kg/m2
- not planning to or currently attempting to gain or lose weight
- low reported omega-3 fatty acid intake per Omega-3 Checklist
- Metabolic Syndrome as define 3/5 of the following:Waist circumference: men > 102 cm women > 88 cm, triglycerides > 150 mg/dL, HDL cholesterol: men < 40 mg/dL women < 50 mg/dL,Blood pressure >130/>85 mmHg,Fasting glucose > 100 mg/dL (Hypertensive subjects are eligible if taking thiazide diuretics NOT ACE inhibitors beta blockers)
Key exclusion criteria (15 listed)
- smoke or use tobacco or nicotine in any form (including pills and patches)
- take any medication that makes you unable to exercise
- have established cardiovascular, pulmonary, and/or metabolic disease such as diabetes
- have uncontrolled hypertension
- have alcohol, anabolic steroid, or other substance abuse issues
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 |
|---|---|---|
| Moderate Physical ExerciseThis intervention is comprised of two separate visits at least one week apart. The purpose of visit 1 is to determine the cycle ergometer workload that produces a moderate exercise intensity of 60% heart rate reserve to be used on visit 2. The purpose of visit 2 is to determine changes in platelet reactivity in response to moderate exercise. | Other | – |
Primary outcome
Platelet Reactivity
Time frame: Baseline, post-intervention (24 hours), & time points during the exercise phase: prior to exercise (-25 min, -10 min, - 1 min), 10 minutes into the routine, at completion (25 minutes), and 20 & 60 minutes following completion
We hypothesize that moderate physical exercise will increase platelet reactivity in sedentary individuals with metabolic syndrome. Platelet reactivity will be measured by flow cytometry using anti-CD61 antibodies as a marker for platelets and anti-CD62 (P-selectin) as a marker of platelet activation. This will be measured at baseline, post-intervention and time points post-baseline in each subject.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Matthew Picklo, PhD principal investigator
USDA Grand Forks Human Nutrition Research Center
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome, run by USDA Grand Forks Human Nutrition Research Center.
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 5 inclusion and 15 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: withdrawn, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Platelet Reactivity (time frame: Baseline, post-intervention (24 hours), & time points during the exercise phase: prior to exercise (-25 min, -10 min, - 1 min), 10 minutes into the routine, at completion (25 minutes), and 20 & 60 minutes following completion). 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 2 Feb 2022; AzTrials last refreshed its copy on 31 Oct 2026.