Clinical trial NCT04051229: 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
Overall status: TERMINATED
Phase: NA
Conditions: PreDiabetes
Sedentary Lifestyle
Keywords: Metabolic Flexibility
Exercise Induced Metabolic Flexibility
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 10
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Metabolic Rate-Baseline
timeFrame: Baseline
measure: Metabolic Rate_6 weeks after exercise training program
timeFrame: 6 weeks exercise training program
measure: Blood collection_lactate Baseline
timeFrame: Baseline
measure: Blood collection_lactate follow up 1
timeFrame: 6 weeks exercise training program
measure: Blood collection_lactate follow up 2
timeFrame: 3-10 days following Follow-Up Test 1
measure: Blood collection_glucose baseline
timeFrame: Baseline
measure: Blood collection_glucose follow up 1
timeFrame: 6 weeks exercise training program
measure: Blood collection_glucose follow up 2
timeFrame: 3-10 days following Follow-Up Test 1
measure: Blood collection_nonesterified fatty acids
timeFrame: Baseline
measure: Blood collection_nonesterified fatty acids follow up 1
timeFrame: 6 weeks exercise training program
measure: Blood collection_nonesterified fatty acids follow up 2
timeFrame: 3-10 days following Follow-Up Test 1
measure: Blood collection_insulin
timeFrame: Baseline
measure: Blood collection_insulin follow up 1
timeFrame: 6 weeks exercise training program
measure: Blood collection_insulin follow up 2
timeFrame: 3-10 days following Follow-Up Test 1
Secondary outcomes:
measure: VO2 peak
timeFrame: Baseline (Pre-exercise training)
measure: VO2 peak
timeFrame: 6 weeks (Post exercise training)
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Department of Health and Exercise Science Clinical Research Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center Clinical Research Unit
state: North Carolina
Study officials:
affiliation: Wake Forest Department of Health and Exercise Science
name: Gary Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References: