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Exercise Training and Metabolic Flexibility in Prediabetes

Primary Purpose

PreDiabetes, Sedentary Lifestyle

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
6-week exercise training program
Standardized isoenergetic high fat diet
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for PreDiabetes focused on measuring Metabolic Flexibility, Exercise Induced Metabolic Flexibility

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Health and Exercise Science Clinical Research Center
  • Wake Forest Baptist Medical Center Clinical Research Unit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise Training Group

Arm Description

All 20 participants will be assigned to this arm. These individuals will participate in 6 weeks of a moderate supervised aerobic exercise training program.

Outcomes

Primary Outcome Measures

Metabolic Rate-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.
Metabolic Rate_6 weeks after 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.
Blood collection_lactate 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.
Blood collection_lactate follow up 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.
Blood collection_lactate follow up 2
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.
Blood collection_glucose 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.
Blood collection_glucose follow up 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.
Blood collection_glucose follow up 2
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.
Blood collection_nonesterified fatty acids
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.
Blood collection_nonesterified fatty acids follow up 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.
Blood collection_nonesterified fatty acids follow up 2
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.
Blood collection_insulin
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.
Blood collection_insulin follow up 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.
Blood collection_insulin follow up 2
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

VO2 peak
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.
VO2 peak
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.

Full Information

First Posted
August 7, 2019
Last Updated
October 13, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04051229
Brief Title
Exercise Training and Metabolic Flexibility in Prediabetes
Official Title
The Effect of an Exercise Training Program on Metabolic Flexibility in Older Adults With Prediabetes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to financial limitations and time commitments, I am requesting the closure of this research
Study Start Date
October 29, 2019 (Actual)
Primary Completion Date
August 17, 2022 (Actual)
Study Completion Date
August 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Sedentary Lifestyle
Keywords
Metabolic Flexibility, Exercise Induced Metabolic Flexibility

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Training Group
Arm Type
Experimental
Arm Description
All 20 participants will be assigned to this arm. These individuals will participate in 6 weeks of a moderate supervised aerobic exercise training program.
Intervention Type
Behavioral
Intervention Name(s)
6-week exercise training program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standardized isoenergetic high fat diet
Intervention Description
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 Measure Information:
Title
Metabolic Rate-Baseline
Description
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.
Time Frame
Baseline
Title
Metabolic Rate_6 weeks after exercise training program
Description
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.
Time Frame
6 weeks exercise training program
Title
Blood collection_lactate Baseline
Description
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.
Time Frame
Baseline
Title
Blood collection_lactate follow up 1
Description
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.
Time Frame
6 weeks exercise training program
Title
Blood collection_lactate follow up 2
Description
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.
Time Frame
3-10 days following Follow-Up Test 1
Title
Blood collection_glucose baseline
Description
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.
Time Frame
Baseline
Title
Blood collection_glucose follow up 1
Description
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.
Time Frame
6 weeks exercise training program
Title
Blood collection_glucose follow up 2
Description
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.
Time Frame
3-10 days following Follow-Up Test 1
Title
Blood collection_nonesterified fatty acids
Description
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.
Time Frame
Baseline
Title
Blood collection_nonesterified fatty acids follow up 1
Description
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.
Time Frame
6 weeks exercise training program
Title
Blood collection_nonesterified fatty acids follow up 2
Description
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.
Time Frame
3-10 days following Follow-Up Test 1
Title
Blood collection_insulin
Description
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.
Time Frame
Baseline
Title
Blood collection_insulin follow up 1
Description
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.
Time Frame
6 weeks exercise training program
Title
Blood collection_insulin follow up 2
Description
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.
Time Frame
3-10 days following Follow-Up Test 1
Secondary Outcome Measure Information:
Title
VO2 peak
Description
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.
Time Frame
Baseline (Pre-exercise training)
Title
VO2 peak
Description
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.
Time Frame
6 weeks (Post exercise training)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Miller, PhD
Organizational Affiliation
Wake Forest Department of Health and Exercise Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Health and Exercise Science Clinical Research Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27105
Country
United States
Facility Name
Wake Forest Baptist Medical Center Clinical Research Unit
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercise Training and Metabolic Flexibility in Prediabetes

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