Exercise Training and Metabolic Flexibility in Prediabetes

PreDiabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04051229
• Other study ID #: IRB00058517
• Secondary ID: 10000441
• Status: Terminated
• Phase: N/A
• Start date: October 29, 2019
• Est. completion date: August 17, 2022

Study information

• Verified date: June 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: August 17, 2022
• Est. primary completion date: August 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• PreDiabetes
• Prediabetic State
• Sedentary Lifestyle

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Department of Health and Exercise Science Clinical Research Center	Winston-Salem	North Carolina
United States	Wake Forest Baptist Medical Center Clinical Research Unit	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	6 weeks exercise training program
Primary	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.	Baseline
Primary	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.	6 weeks exercise training program
Primary	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.	3-10 days following Follow-Up Test 1
Primary	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.	Baseline
Primary	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.	6 weeks exercise training program
Primary	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.	3-10 days following Follow-Up Test 1
Primary	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.	Baseline
Primary	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.	6 weeks exercise training program
Primary	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.	3-10 days following Follow-Up Test 1
Primary	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.	Baseline
Primary	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.	6 weeks exercise training program
Primary	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.	3-10 days following Follow-Up Test 1
Secondary	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.	Baseline (Pre-exercise training)
Secondary	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.	6 weeks (Post exercise training)