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Exercise Training and Metabolic Flexibility in Prediabetes

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ClinicalTrials.gov Identifier: NCT04051229
Recruitment Status : Not yet recruiting
First Posted : August 9, 2019
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
The purpose of the study is to determine if a 6-week exercise training program promotes exercise-induced metabolic flexibility, that is, the ability to switch fuel sources for energy, in older prediabetic adults.

Condition or disease Intervention/treatment Phase
PreDiabetes Sedentary Lifestyle Behavioral: 6-week exercise training program Behavioral: Standardized isoenergetic high fat diet Not Applicable

Detailed Description:

This is an investigator initiated single group intervention trial. All participants will receive a 6-week exercise training program with testing occurring before and following the training program. Participants will be provided with 3 days of a high fat diet prior to each of the three testing sessions at the Clinical Research Unit. All who agree to participate will undergo the same intervention.

The goal of this proposal is to study the impact of a 6-week moderate intensity walking training program on exercise induced lipid metabolic flexibility in older adults with prediabetes. Study Investigators will seek to determine if exercise induced lipid oxidation following a high fat diet is increased in trained individuals relative to their baseline.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Participants will be compared to their individual pre-intervention states. All 20 subjects will be placed in the same group and asked to follow the same exercise protocol.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of an Exercise Training Program on Metabolic Flexibility in Older Adults With Prediabetes
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise Training Group
All 20 participants will be assigned to this arm. These individuals will participate in 6 weeks of a moderate supervised aerobic exercise training program.
Behavioral: 6-week exercise training program
Participants will walk at 50% Heart Rate Reserve (HRR) 3 to 5 days per week for 6 weeks at the Department of Health and Exercise Science Clinical Research Center under the supervision of study staff.

Behavioral: Standardized isoenergetic high fat diet
Prior to the submaximal exercise testing visits, all participants will be provided with 3 days of a standardized isoenergetic high fat diet (20% of kcals from carbohydrate, 65% fat; 15% protein) to promote lipid oxidation. The meals will be prepared and provided by the Clinical Research Unit of Wake Forest Baptist Health. Participants will pick up 3 days' worth of food and snacks 4 days prior the testing visit. For the 3 days leading up to the visit, participants will eat the provided foods and complete a compliance assessment.




Primary Outcome Measures :
  1. Metabolic Rate-Baseline [ Time Frame: Baseline ]
    Metabolic rate will be measured by gas exchange using indirect calorimeter. For the first (baseline test) and second (follow up test 1) time we monitor gas exchange, participants will exercise for 20 minutes at a workload that elicits 50% of maximal oxygen consumption as determined by Graded Exercise Test #1 done before the exercise training program. The third time (follow up test 2), participants will exercise for 20 minutes at a workload that elicits 50% of oxygen consumption as determined by Graded Exercise Test #2 done after the exercise training program.

  2. Metabolic Rate_6 weeks after exercise training program [ Time Frame: 6 weeks exercise training program ]
    Metabolic rate will be measured by gas exchange using indirect calorimeter. For the first (baseline test) and second (follow up test 1) time we monitor gas exchange, participants will exercise for 20 minutes at a workload that elicits 50% of maximal oxygen consumption as determined by Graded Exercise Test #1 done before the exercise training program. The third time (follow up test 2), participants will exercise for 20 minutes at a workload that elicits 50% of oxygen consumption as determined by Graded Exercise Test #2 done after the exercise training program.

  3. Blood collection_lactate Baseline [ Time Frame: Baseline ]
    At baseline and follow-up testing visits, 6 blood samples at each visit (times 0, 5, 10, 15, 20, and 50) will be obtained for measures of lactate. Blood draws will happen as gas exchange is being measured. 1 tsp of blood will be taken through a catheter at each time point.

  4. Blood collection_lactate follow up 1 [ Time Frame: 6 weeks exercise training program ]
    At baseline and follow-up testing visits, 6 blood samples at each visit (times 0, 5, 10, 15, 20, and 50) will be obtained for measures of lactate. Blood draws will happen as gas exchange is being measured. 1 tsp of blood will be taken through a catheter at each time point.

  5. Blood collection_lactate follow up 2 [ Time Frame: 3-10 days following Follow-Up Test 1 ]
    At baseline and follow-up testing visits, 6 blood samples at each visit (times 0, 5, 10, 15, 20, and 50) will be obtained for measures of lactate. Blood draws will happen as gas exchange is being measured. 1 tsp of blood will be taken through a catheter at each time point.

  6. Blood collection_glucose baseline [ Time Frame: Baseline ]
    At baseline and follow-up testing visits, 6 blood samples at each visit (times 0, 5, 10, 15, 20, and 50) will be obtained for measures of glucose. Blood draws will happen as gas exchange is being measured. 1 tsp of blood will be taken through a catheter at each time point.

  7. Blood collection_glucose follow up 1 [ Time Frame: 6 weeks exercise training program ]
    At baseline and follow-up testing visits, 6 blood samples at each visit (times 0, 5, 10, 15, 20, and 50) will be obtained for measures of glucose. Blood draws will happen as gas exchange is being measured. 1 tsp of blood will be taken through a catheter at each time point.

  8. Blood collection_glucose follow up 2 [ Time Frame: 3-10 days following Follow-Up Test 1 ]
    At baseline and follow-up testing visits, 6 blood samples at each visit (times 0, 5, 10, 15, 20, and 50) will be obtained for measures of glucose. Blood draws will happen as gas exchange is being measured. 1 tsp of blood will be taken through a catheter at each time point.

  9. Blood collection_nonesterified fatty acids [ Time Frame: Baseline ]
    At baseline and follow-up testing visits, 6 blood samples at each visit (times 0, 5, 10, 15, 20, and 50) will be obtained for measures of nonesterified fatty acids. Blood draws will happen as gas exchange is being measured. 1 tsp of blood will be taken through a catheter at each time point.

  10. Blood collection_nonesterified fatty acids follow up 1 [ Time Frame: 6 weeks exercise training program ]
    At baseline and follow-up testing visits, 6 blood samples at each visit (times 0, 5, 10, 15, 20, and 50) will be obtained for measures of nonesterified fatty acids. Blood draws will happen as gas exchange is being measured. 1 tsp of blood will be taken through a catheter at each time point.

  11. Blood collection_nonesterified fatty acids follow up 2 [ Time Frame: 3-10 days following Follow-Up Test 1 ]
    At baseline and follow-up testing visits, 6 blood samples at each visit (times 0, 5, 10, 15, 20, and 50) will be obtained for measures of nonesterified fatty acids. Blood draws will happen as gas exchange is being measured. 1 tsp of blood will be taken through a catheter at each time point.

  12. Blood collection_insulin [ Time Frame: Baseline ]
    At baseline and follow-up testing visits, 6 blood samples at each visit (times 0, 5, 10, 15, 20, and 50) will be obtained for measures of insulin. Blood draws will happen as gas exchange is being measured. 1 tsp of blood will be taken through a catheter at each time point.

  13. Blood collection_insulin follow up 1 [ Time Frame: 6 weeks exercise training program ]
    At baseline and follow-up testing visits, 6 blood samples at each visit (times 0, 5, 10, 15, 20, and 50) will be obtained for measures of insulin. Blood draws will happen as gas exchange is being measured. 1 tsp of blood will be taken through a catheter at each time point.

  14. Blood collection_insulin follow up 2 [ Time Frame: 3-10 days following Follow-Up Test 1 ]
    At baseline and follow-up testing visits, 6 blood samples at each visit (times 0, 5, 10, 15, 20, and 50) will be obtained for measures of insulin. Blood draws will happen as gas exchange is being measured. 1 tsp of blood will be taken through a catheter at each time point.


Secondary Outcome Measures :
  1. VO2 peak [ Time Frame: Baseline (Pre-exercise training) ]
    The gold standard for assessing cardiovascular fitness is exercise capacity as determined from peak volume of oxygen consumption (VO2peak) and treadmill time during a graded exercise test. A physician supervised, individualized ramp treadmill protocol will be performed on each participant. In this protocol, participants walk at a brisk pace with the speed based on their comfort and fitness. For lower fit individuals, the grade will be increased at a rate of 1%/minute, and for higher fit individuals, the grade will be increased at a rate of 2%/minute. The treadmill test will be performed according to guidelines set by the American College of Sports Medicine (ACSM, 2014), to evaluate the subject's cardiovascular response to exercise.

  2. VO2 peak [ Time Frame: 6 weeks (Post exercise training) ]
    The gold standard for assessing cardiovascular fitness is exercise capacity as determined from peak volume of oxygen consumption (VO2peak) and treadmill time during a graded exercise test. A physician supervised, individualized ramp treadmill protocol will be performed on each participant. In this protocol, participants walk at a brisk pace with the speed based on their comfort and fitness. For lower fit individuals, the grade will be increased at a rate of 1%/minute, and for higher fit individuals, the grade will be increased at a rate of 2%/minute. The treadmill test will be performed according to guidelines set by the American College of Sports Medicine (ACSM, 2014), to evaluate the subject's cardiovascular response to exercise.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥60 years of age
  • Sedentary prior to the start of the training program (self-reported: less than 30 minutes of exercise for no more than 1 day a week)
  • Prediabetes (measured at first screening: HbA1c = 5.7-6.5%)
  • Must be able to pick-up and consume study provided foods
  • Willingness to provide informed consent and participate in the intervention
  • Must obtain transportation to visits and intervention training sessions
  • No contraindications for involvement in a moderate exercise training program or exercise testing procedures by self-report

Exclusion Criteria:

  • Self-reported diagnosis of a metabolic or chronic disease such as cardiovascular disease, diabetes, Chronic Obstructive Pulmonary Disease, or movement disorders such as Parkinson's disease, Ataxia, Huntington's Disease
  • Current or recent (<12 months) treatment for cancer
  • Body Mass Index <18.5 or >/30.0 kg/m2
  • Tobacco users
  • Febrile or chronic infection within study period
  • Aversion to testing procedures
  • Hypertension, hyperthyroidism, hypothyroidism
  • Unwilling to abstain from ingesting caffeine during study testing periods
  • Unwilling to withhold medications that affect metabolic rate during testing periods
  • Physically active (>30 minutes per day on more than 1 day per week)
  • ECGs that indicate cardiac injury or contraindications to treadmill testing
  • Allergic or intolerant to any study-provided foods

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04051229


Contacts
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Contact: Katharine A Cunnane 9804068785 cunnka16@wfu.edu
Contact: Gary Miller, PhD 3367581901 millergd@wfu.edu

Locations
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United States, North Carolina
Department of Health and Exercise Science Clinical Research Center Not yet recruiting
Winston-Salem, North Carolina, United States, 27105
Contact: Erika Johnson, MS    336-758-3486    grifel12@wfu.edu   
Wake Forest Baptist Medical Center Clinical Research Unit Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Elizabeth Poteat    336-713-0049    epoteat@wakehealth.edu   
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Gary Miller, PhD Wake Forest Department of Health and Exercise Science

Additional Information:
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04051229     History of Changes
Other Study ID Numbers: IRB00058517
10000441 ( Other Grant/Funding Number: Translational Science Center )
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
Metabolic Flexibility
Exercise Induced Metabolic Flexibility

Additional relevant MeSH terms:
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Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia