Aerobic Treadmill Exercise And Metabolism


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Verified May 2017 by University of South Carolina

Sponsor:

Information provided by (Responsible Party):

Joshua Sparks, University of South Carolina

ClinicalTrials.gov Identifier:

NCT03162991

First received: May 19, 2017

Last updated: May 19, 2017

Last verified: May 2017

Overview- In this study, overweight or obese, sedentary participants (age=35-55 years, n=20) will be randomized to a 12-week control period or an aerobic exercise intervention. Those randomized into the control group will then complete the exercise intervention subsequently. The planned energy expenditure per week of exercise will be 10-12 kilocalories per kilogram of body weight per week. Participants will complete three non-consecutive exercise sessions per week. Body weight, resting metabolic rate via indirect calorimetry, peak oxygen consumption (VO2peak) through graded exercise testing, fasting blood samples, CGM, sleep and dietary habits via self-report, and physical activity monitoring will be completed at prior to and following the aerobic exercise intervention.

Metabolism Disorder, Glucose
Physical Activity
Sedentary Lifestyle
Other: Aerobic Exercise Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Basic Science
Official Title: The Effect of a 12-Week Aerobic Treadmill Exercise on Markers of Glucose Metabolism

Primary Outcome Measures:

  • Continuous Glucose Monitoring [ Time Frame: 3-6 months ]

    Fasting, Postprandial, and Matched Time Point Glucose Measurements

  • Glucose Regulatory Hormones [ Time Frame: 3-6 months ]

    Fasting blood concentrations of Glucose Regulatory Hormones

Estimated Enrollment: 20
Anticipated Study Start Date: June 26, 2017
Estimated Study Completion Date: August 31, 2018
Estimated Primary Completion Date: August 31, 2018 (Final data collection date for primary outcome measure)
Experimental: 12-Week Aerobic Exercise Intervention Other: Aerobic Exercise Intervention

Aerobic Exercise Intervention- 12-weeks, exercise 3 non-consecutive days/week for ~30-55 minutes per exercise session.

No Intervention: 12-Week Control Period

Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. be age 35-55 years of age,
  2. have 30≤body mass index (BMI)≤35 kg/m2,
  3. be weight stable (±2%) during the previous 3 months,
  4. have ˂120 minutes of resistance or endurance exercise per week during the previous 3 months, and
  5. for females, be eumenorrheic, or post-menopausal for ≥1 year.

Exclusion Criteria:

  1. self-reported medical conditions (e.g. diabetes), cardiovascular diseases, chronic or recurrent respiratory conditions (e.g. uncontrolled asthma or chronic obstructive pulmonary disease), active cancer, and eating, or neurological disorders,
  2. medications that affect metabolism (e.g. thyroid medications, statins),
  3. psychological issues, including but not limited to untreated depression and attention deficit disorder,
  4. excessive caffeine use (>500 mg/day),
  5. smoking during the past year,
  6. pregnant or lactating females,
  7. unwillingness to provide informed consent.

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: NCT03162991

University of South Carolina

Responsible Party: Joshua Sparks, PhD Candidate; Graduate/Research Assistant, University of South Carolina
ClinicalTrials.gov Identifier: NCT03162991     History of Changes
Other Study ID Numbers: Pro00067271
Study First Received: May 19, 2017
Last Updated: May 19, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Metabolic Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 22, 2017