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Clinical Trials/NCT04051229
NCT04051229
Terminated
Not Applicable

The Effect of an Exercise Training Program on Metabolic Flexibility in Older Adults With Prediabetes

Wake Forest University Health Sciences2 sites in 1 country10 target enrollmentOctober 29, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PreDiabetes
Sponsor
Wake Forest University Health Sciences
Enrollment
10
Locations
2
Primary Endpoint
Blood collection_nonesterified fatty acids
Status
Terminated
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 29, 2019
End Date
August 17, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 Outcomes

  • VO2 peak(6 weeks (Post exercise training))

Study Sites (2)

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