Type 1 DiabetesT-REXNCT05884814
Timing of Resistance Exercise in Type 1 Diabetes
A study testing Morning exercise, Afternoon exercise and Habitual physical activity levels in people with Type 1 Diabetes, run by Dasman Diabetes Institute at 1 site in Kuwait.
Trial summary
The aims of the current study are 1. to compare the effects of acute morning and afternoon resistance exercise on blood glucose levels in people with type 1 diabetes. 2. to compare the effects of morning and afternoon resistance exercise training on cardiometabolic health outcomes in people with type 1 diabetes Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Morning exercise, Afternoon exercise and Habitual physical activity levels
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteKuwait
- Study dates
- 1 Jul 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Physician confirmed type 1 diabetes for at least 1 year
- Stable insulin therapy for 3 months prior to the study
Who cannot join
- BMI of 45 or higher
- BP of 160/100mmHg or higher
- autonomic neuropathy
- severe proliferative retinopathy
- joint or limb injuries preventing weight-bearing activity
- autonomic neuropathy
- severe proliferative retinopathy
- any other medical condition that prevents participants from exercising safely.
Trial locations and contacts
1 site in 1 country.
Kuwait1 site, 1 recruiting
- Recruiting
Dasman Diabetes Institute
Kuwait City, 15462
Ebaa AlOZairi
Ebaa AlOzairi
About this study
Official title: Timing of Resistance Exercise, Glucose Control and Exercise Adaptations in People With Type 1 Diabetes: a Randomised-controlled Trial
The aims of the current study are
- to compare the effects of acute morning and afternoon resistance exercise on blood glucose levels in people with type 1 diabetes.
- to compare the effects of morning and afternoon resistance exercise training on cardiometabolic health outcomes in people with type 1 diabetes
- Conditions
- Type 1 Diabetes
- Being tested
- Morning exercise, Afternoon exercise, Habitual physical activity levels
- Keywords
- exercise, circadian rhythm, glucose control, muscle, strength
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morning exerciseBehavioural
Between 6-10am participants will attend the gym and perform 10 min of warm up exercise, 3 sets of 7 resistance exercises ( leg press, calf press, leg curl, chest press, lateral raise, seated row and plank)
Afternoon exerciseBehavioural
Between 4-8pm participants will attend the gym and perform 10 min of warm up exercise, 3 sets of 7 resistance exercises ( leg press, calf press, leg curl, chest press, lateral raise, seated row and plank)
Habitual physical activity levelsBehavioural
Participants will be asked to maintain their normal activity levels
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Habitual physical activity Receives: Behavioral: Habitual physical activity levels |
| Morning exercise | Active comparator | Exercise training between 6-10am Receives: Behavioral: Morning exercise |
| Afternoon exercise | Active comparator | Exercise training between 4-8pm Receives: Behavioral: Afternoon exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle strength
Sum of one repetition maximum for the 7 resistance exercise
Measured: Change from baseline to 12 weeks
Change in interstitial glucose time in range
Interstitial glucose time in range (3.9-10mmol/L) measured via continuous glucose monitoring
Measured: Change from 6 hours before (baseline) to 6 hours after (post-exercise) an exercise training session
Secondary outcomes (8)
Change in appendicular skeletal muscle mass
Measured by DEXA
Measured: Change from baseline to 12 weeks
Change in whole body fat mass
Measured by DEXA
Measured: Change from baseline to 12 weeks
Change in physical function
Measured by the short performance physical battery
Measured: Change from baseline to 12 weeks
Change in HbA1c
HbA1c concentration
Measured: Change from baseline to 12 weeks
Change in interstitial glucose average
Interstitial average glucose measured via continuous glucose monitoring
Measured: Change from 6 hours before (baseline) to 6 hours after (post-exercise) an exercise training session
Change in interstitial glucose variability
Interstitial glucose variability measured via continuous glucose monitoring
Measured: Change from 6 hours before (baseline) to 6 hours after (post-exercise) an exercise training session
Change in interstitial glucose time in hypoglycaemia
Interstitial glucose time in range (<3.9mmol/L) measured via continuous glucose monitoring
Measured: Change from 6 hours before (baseline) to 6 hours after (post-exercise) an exercise training session
Change in interstitial glucose time in hyperglycaemia
Interstitial glucose time in range (>10mmol/L) measured via continuous glucose monitoring
Measured: Change from 6 hours before (baseline) to 6 hours after (post-exercise) an exercise training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 Jul 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1:1 parallel group design
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dasman Diabetes Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ebaa Al Ozairi, Dasman Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884814
- Sponsor's protocol ID
- RA HM-2023-009
- Acronym
- T-REX
- Status last verified
- Jul 2023
- First submitted
- 10 May 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al Ozairi ES, Hamdan YG, Al Awadhi AA, Al Otaibi NB, Baqer AH, West DJ, Taliping DR, Al Kandari JA, Gray SR. A Comparison of the Effects of the Timing of Resistance Exercise on Glucose Levels Within the Target Range in People With Type 1 Diabetes (TREX Study): A Randomized Crossover Trial. Diabetes Metab Res Rev. 2026 Jul;42(5):e70190. doi: 10.1002/dmrr.70190.
PubMed 42265980
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Resistance Exercise, Glucose Control and Exercise Adaptations in People With Type 1 Diabetes: a Randomised-controlled Trial
- ClinicalTrials.gov ID
- NCT05884814
- Acronym / sponsor ID
- T-REX / RA HM-2023-009
- Conditions
- Type 1 Diabetes
- Keywords
- exercise, circadian rhythm, glucose control, muscle, strength
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Dasman Diabetes InstituteUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Jun 2023 (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 aims of the current study are
- to compare the effects of acute morning and afternoon resistance exercise on blood glucose levels in people with type 1 diabetes.
- to compare the effects of morning and afternoon resistance exercise training on cardiometabolic health outcomes in people with type 1 diabetes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 1:1:1 parallel group design
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: Habitual physical activity levelsHabitual physical activity |
| Morning exercise | Active comparator | Behavioral: Morning exerciseExercise training between 6-10am |
| Afternoon exercise | Active comparator | Behavioral: Afternoon exerciseExercise training between 4-8pm |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Physician confirmed type 1 diabetes for at least 1 year
- Stable insulin therapy for 3 months prior to the study
Key exclusion criteria (8 listed)
- BMI of 45 or higher
- BP of 160/100mmHg or higher
- autonomic neuropathy
- severe proliferative retinopathy
- joint or limb injuries preventing weight-bearing activity
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 |
|---|---|---|
| Morning exerciseBetween 6-10am participants will attend the gym and perform 10 min of warm up exercise, 3 sets of 7 resistance exercises ( leg press, calf press, leg curl, chest press, lateral raise, seated row and plank) | Behavioural | Morning exercise |
| Afternoon exerciseBetween 4-8pm participants will attend the gym and perform 10 min of warm up exercise, 3 sets of 7 resistance exercises ( leg press, calf press, leg curl, chest press, lateral raise, seated row and plank) | Behavioural | Afternoon exercise |
| Habitual physical activity levelsParticipants will be asked to maintain their normal activity levels | Behavioural | Control |
Primary outcome
Change in muscle strength
Time frame: Change from baseline to 12 weeks
Sum of one repetition maximum for the 7 resistance exercise
Change in interstitial glucose time in range
Time frame: Change from 6 hours before (baseline) to 6 hours after (post-exercise) an exercise training session
Interstitial glucose time in range (3.9-10mmol/L) measured via continuous glucose monitoring
8 secondary outcomes
Change in appendicular skeletal muscle mass
Time frame: Change from baseline to 12 weeks
Change in whole body fat mass
Time frame: Change from baseline to 12 weeks
Change in physical function
Time frame: Change from baseline to 12 weeks
Change in HbA1c
Time frame: Change from baseline to 12 weeks
Change in interstitial glucose average
Time frame: Change from 6 hours before (baseline) to 6 hours after (post-exercise) an exercise training session
Change in interstitial glucose variability
Time frame: Change from 6 hours before (baseline) to 6 hours after (post-exercise) an exercise training session
Change in interstitial glucose time in hypoglycaemia
Time frame: Change from 6 hours before (baseline) to 6 hours after (post-exercise) an exercise training session
Change in interstitial glucose time in hyperglycaemia
Time frame: Change from 6 hours before (baseline) to 6 hours after (post-exercise) an exercise training session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Derived from this study: PubMed 42265980Al Ozairi ES, Hamdan YG, Al Awadhi AA, Al Otaibi NB, Baqer AH, West DJ, Taliping DR, Al Kandari JA, Gray SR. A Comparison of the Effects of the Timing of Resistance Exercise on Glucose Levels Within the Target Range in People With Type 1 Diabetes (TREX Study): A Randomized Crossover Trial. Diabetes Metab Res Rev. 2026 Jul;42(5):e70190. doi: 10.1002/dmrr.70190.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morning exercise, Afternoon exercise and Habitual physical activity levels in people with Type 1 Diabetes, run by Dasman Diabetes Institute at 1 site in Kuwait.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 28 Jul 2023. 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 Kuwait. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ebaa AlOzairi, MBChB (+965 22242999, ebaa.alozairi@dasmaninstitute.rog), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle strength (time frame: Change from baseline to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05884814, which also lists 1 linked publication.
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 28 Jul 2023.