- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01872273
Blood Cell Response to Exercise
January 18, 2022 updated by: USDA Grand Forks Human Nutrition Research Center
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 Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Obese adults with Metabolic Syndrome
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Matthew Picklo, PhD, USDA Grand Forks Human Nutrition Research Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
May 1, 2013
First Submitted That Met QC Criteria
June 6, 2013
First Posted (Estimate)
June 7, 2013
Study Record Updates
Last Update Posted (Actual)
February 2, 2022
Last Update Submitted That Met QC Criteria
January 18, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GFHNRC026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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