Blood Cell Response to Exercise

NCT01872273 | Withdrawn

• 1 other identifier: GFHNRC026
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metabolic Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Interventions

Moderate Physical Exercise OTHER

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 Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Obese adults with Metabolic Syndrome

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• USDA Grand Forks Human Nutrition Research Center: lead

MeSH Terms

Conditions

Metabolic Syndrome; Obesity; Overweight; Hypertension; Hyperlipidemias; Hyperglycemia

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders

Study Officials

• Matthew Picklo, PhD

  USDA Grand Forks Human Nutrition Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2013
• First Posted: June 7, 2013
• Study Start: February 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 2, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share