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Blood Cell Response to Exercise

Blood Cell Response to Exercise

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01872273
Enrollment
0
Registered
2013-06-07
Start date
2013-02-28
Completion date
2016-06-30
Last updated
2022-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Keywords

Metabolic Syndrome, Obese, Overweight, Hypertension, Hyperlipidemia, Glucose Intolerant, High blood sugar, Exercise in obesity, Platelets

Brief 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. This study is being done to determine how platelets respond when a person performs an initial period of moderate exercise.

Interventions

OTHERModerate Physical Exercise

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.

Sponsors

USDA Grand Forks Human Nutrition Research Center
Lead SponsorFED

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Platelet ReactivityBaseline, 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 completionWe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026