Blood Cell Response to Exercise

Metabolic Syndrome Clinical Trial

Official title:

Blood Cell Response to Exercise

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01872273
• Other study ID #: GFHNRC026
• Status: Withdrawn
• Start date: February 2013
• Est. completion date: June 2016

Study information

• Verified date: January 2022
• Source: USDA Grand Forks Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Metabolic Syndrome

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
USDA Grand Forks Human Nutrition Research Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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