Diabetes Mellitus, Type 2NCT06366399
The Acute T-Rex (Timing of Resistance Exercise) Study
A study testing Resistance Exercise Timing in people with Diabetes Mellitus, Type 2 and Insulin Resistance, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Insulin Resistance, Glucose Intolerance
- What is being tested?
- Resistance Exercise Timing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Diagnosis of insomnia, sleep apnea, or other sleep and circadian disorders
- Non-English speaking
- HbA1c >6.5%
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Utah HPER E Buildling
Salt Lake City, Utah, 84112
Jason V Thomas, MS, jason.v.thomas@utah.edu
Tanya M Halliday, PhD
About this study
Official title: Timing (AM v PM) of Acute Resistance Exercise on Glycemic Control in Older Adults: The Acute T-Rex Study
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.
- Conditions
- Diabetes Mellitus, Type 2, Insulin Resistance, Glucose Intolerance, Sleep Disturbance, Overweight or Obesity, Insulin Sensitivity
- Being tested
- Resistance Exercise Timing
- Keywords
- Resistance Exercise, Strength-training, Sleep, Circadian Rhythm
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance, Glucose Intolerance, Parasomnias, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Exercise TimingBehavioural
Also called Exercise, Strength-Training, Weightlifting
1 resistance exercise session consisting of 3 sets, 10 repetitions per set, on 12 different exercises
| Study group | Role | What they receive |
|---|---|---|
| AM Resistance Exercise | Experimental | Resistance Exercise intervention taking place in the AM Receives: Behavioral: Resistance Exercise Timing |
| PM Resistance Exercise | Experimental | Resistance Exercise intervention taking place in the PM Receives: Behavioral: Resistance Exercise Timing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Insulin sensitivity will be calculated using the Matsuda Insulin Sensitivity Index
Measured: 1 day
Secondary outcomes (1)
Sleep Duration
Sum of time spent in stage 1, stage 2, stage 3 and rapid eye movement stage (REM) as assessed via polysomnography.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start15 Nov 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366399
- Sponsor's protocol ID
- 00156659
- Status last verified
- Mar 2025
- First submitted
- 31 Jan 2024
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing (AM v PM) of Acute Resistance Exercise on Glycemic Control in Older Adults: The Acute T-Rex Study
- ClinicalTrials.gov ID
- NCT06366399
- Acronym / sponsor ID
- 00156659
- Conditions
- Diabetes Mellitus, Type 2, Insulin Resistance, Glucose Intolerance, Sleep Disturbance, Overweight or Obesity, Insulin Sensitivity
- Keywords
- Resistance Exercise, Strength-training, Sleep, Circadian Rhythm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AM Resistance Exercise | Experimental | Behavioral: Resistance Exercise TimingResistance Exercise intervention taking place in the AM |
| PM Resistance Exercise | Experimental | Behavioral: Resistance Exercise TimingResistance Exercise intervention taking place in the PM |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance Exercise TimingAlso: Exercise, Strength-Training, Weightlifting1 resistance exercise session consisting of 3 sets, 10 repetitions per set, on 12 different exercises | Behavioural | AM Resistance Exercise, PM Resistance Exercise |
Primary outcome
Insulin sensitivity
Time frame: 1 day
Insulin sensitivity will be calculated using the Matsuda Insulin Sensitivity Index
1 secondary outcome
Sleep Duration
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise Timing in people with Diabetes Mellitus, Type 2 and Insulin Resistance, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tanya M Halliday, PhD (801-213-1364, tanya.halliday@utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.