Blood Cell Response to Exercise

This study has been withdrawn prior to enrollment.
(Project never funded. No subjects were recruited.)
Sponsor:
Information provided by (Responsible Party):
Matthew Picklo, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01872273
First received: May 1, 2013
Last updated: June 29, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention
Metabolic Syndrome
Other: Moderate Physical Exercise

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Blood Cell Response to Exercise

Resource links provided by NLM:


Further study details as provided by USDA Grand Forks Human Nutrition Research Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 0
Study Start Date: February 2013
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Moderate 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.
  Eligibility

Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Obese adults with Metabolic Syndrome
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01872273

Sponsors and Collaborators
USDA Grand Forks Human Nutrition Research Center
Investigators
Principal Investigator: Matthew Picklo, PhD USDA Grand Forks Human Nutrition Research Center
  More Information

Responsible Party: Matthew Picklo, PhD, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01872273     History of Changes
Other Study ID Numbers: GFHNRC026 
Study First Received: May 1, 2013
Last Updated: June 29, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by USDA Grand Forks Human Nutrition Research Center:
Metabolic Syndrome
Obese
Overweight
Hypertension
Hyperlipidemia
Glucose Intolerant
High blood sugar
Exercise in obesity
Platelets

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 24, 2016