Exercise Training and Metabolic Flexibility in Prediabetes

Not Applicable

Terminated

• Conditions: Sedentary Lifestyle; PreDiabetes
• Interventions: Behavioral: 6-week exercise training program; Behavioral: Standardized isoenergetic high fat diet

• Registration Number: NCT04051229
• Lead Sponsor: 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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-08-07
• Study First Submitted QC: 2019-08-08
• Study First Posted: 2019-08-09
• Study Start: 2019-10-29
• Primary Completion: 2022-08-17
• Study Completion: 2022-08-17
• Status Verified: 2023-06
• Last Update Submitted: 2023-11-01
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise Training Group	6-week exercise training program	All 20 participants will be assigned to this arm. These individuals will participate in 6 weeks of a moderate supervised aerobic exercise training program.
Exercise Training Group	Standardized isoenergetic high fat diet	All 20 participants will be assigned to this arm. These individuals will participate in 6 weeks of a moderate supervised aerobic exercise training program.

Primary Outcome Measures

Name	Time	Method
Blood collection_nonesterified fatty acids	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	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	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	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	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	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	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	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	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	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	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	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	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	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

Name	Time	Method
VO2 peak	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.

Trial Locations

Locations (2)

Wake Forest Baptist Medical Center Clinical Research Unit; 🇺🇸 Winston-Salem, North Carolina, United States

Department of Health and Exercise Science Clinical Research Center; 🇺🇸 Winston-Salem, North Carolina, United States