Exercise Training and Metabolic Flexibility in Prediabetes

NCT ID: NCT04051229

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-29
• Study Completion Date: 2022-08-17

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.

Conditions

PreDiabetes; Sedentary Lifestyle

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

6-week exercise training program

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary Miller, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest Department of Health and Exercise Science

Locations

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, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

10000441

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00058517

Identifier Type: -

Identifier Source: org_study_id