NCT06366399

Brief Summary

The primary aim of this study is to evaluate if a single bout of AM vs PM resistance exercise has different effects on insulin sensitivity and sleep. A randomized cross-over trial be used to compare resistance exercise at two different times of the day. Each condition will take place in a laboratory setting. Each condition will consist of exercise, overnight sleep, and oral glucose tolerance tests the following day. The AM exercise will occur \~1.5 hours after habitual wake, and PM exercise will occur \~11 hours after habitual wake. After a 2-6 week washout, participants will complete the other condition. The hypothesis is that PM exercise will be more beneficial than AM exercise in improving insulin sensitivity. This study could identify if there is a better time of day to perform resistance exercise to decrease risk of developing Type 2 Diabetes Mellitus.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 15, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

2.1 years

First QC Date

January 31, 2024

Last Update Submit

April 1, 2025

Conditions

Diabetes Mellitus, Type 2Insulin ResistanceGlucose IntoleranceSleep DisturbanceOverweight or ObesityInsulin Sensitivity

Keywords

Resistance ExerciseStrength-trainingSleepCircadian Rhythm

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    Insulin sensitivity will be calculated using the Matsuda Insulin Sensitivity Index

    1 day

Secondary Outcomes (1)

  • Sleep Duration

    1 day

Other Outcomes (9)

  • Sleep Staging

    1 day

  • Sleep Quality

    1 day

  • Sleep Efficiency

    1 day

  • +6 more other outcomes

Study Arms (2)

AM Resistance Exercise

EXPERIMENTAL

Resistance Exercise intervention taking place in the AM

Behavioral: Resistance Exercise Timing

PM Resistance Exercise

EXPERIMENTAL

Resistance Exercise intervention taking place in the PM

Behavioral: Resistance Exercise Timing

Interventions

Resistance Exercise TimingBEHAVIORAL

1 resistance exercise session consisting of 3 sets, 10 repetitions per set, on 12 different exercises

Also known as: Exercise, Strength-Training, Weightlifting
AM Resistance ExercisePM Resistance Exercise

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women, all ethnicities, aged 50-74 years
  • BMI ≥25 kg/m² and \<45 kg/m²
  • Weight stable (less than 5% change in the past 6 months)
  • Generally healthy individuals
  • Not meeting recommended activity guidelines for aerobic or resistance exercise

You may not qualify if:

  • Uncontrolled cardiovascular, metabolic, renal, or pulmonary disease
  • Cancer treatment in the past 5 years
  • Untreated thyroid disease or other medical conditions affecting weight or energy metabolism
  • Current use of weight loss medication or other medications likely to impact energy balance
  • Bariatric surgery or extensive bowel resection in the past 2 years
  • Current or recent history (past 2 years) of eating disorder
  • Diagnosis of insomnia, sleep apnea, or other sleep and circadian disorders
  • Non-English speaking
  • HbA1c \>6.5%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah HPER E Buildling

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin ResistanceGlucose IntoleranceParasomniasOverweightObesity

Interventions

ExerciseResistance Training

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinismHyperglycemiaSleep Wake DisordersNervous System DiseasesMental DisordersOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, Human

Central Study Contacts

Tanya M Halliday, PhD

CONTACT

801-213-1364tanya.halliday@utah.edu

Study Email Study Email

CONTACT

8014487897trexstudy@utah.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2024

First Posted

April 15, 2024

Study Start

November 15, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)