Blood Cell Response to Exercise

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by USDA Grand Forks Human Nutrition Research Center
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: July 8, 2014
Last verified: June 2014
  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: Interventional
Study Design: Intervention Model: Single Group Assignment
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 ]
    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.


Estimated Enrollment: 20
Study Start Date: February 2013
Estimated Primary Completion Date: December 2014 (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
Genders Eligible for Study:   Both
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

Contacts
Contact: Angela Scheett, MPH, RD 701-795-8386 angela.scheett@ars.usda.gov

Locations
United States, North Dakota
Grand Forks Human Nutrition Research Center Recruiting
Grand Forks, North Dakota, United States, 58201
Contact: Angela Scheett, MPH, RD    701-795-8386    angela.scheett@ars.usda.gov   
Principal Investigator: Matthew Picklo, PhD         
Sponsors and Collaborators
USDA Grand Forks Human Nutrition Research Center
Investigators
Principal Investigator: Matthew Picklo, PhD USDA Grand Forks Human Nutiriton Center
  More Information

No publications provided

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: July 8, 2014
Health Authority: United States: Federal Government

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 28, 2014