Type2 Diabetes MellitusNCT06497842
Effort During Resistance Training in Type 2 Diabetes
A study testing High-effort resistance exercise training and Low-effort resistance exercise training in people with Type2 Diabetes Mellitus, run by University of New Mexico at 1 site in United States.
Trial summary
In this study the primary aims are to investigate the effect of resistance exercise training with different degrees of effort on glycemic control and psychological variables in individuals living with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- High-effort resistance exercise training and Low-effort resistance exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2024to 5 Mar 2026
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Living with type 2 diabetes mellitus
Who cannot join
- Have a significant cognitive impairment,
- Are non-ambulatory,
- Have lower extremity amputation,
- Have renal failure,
- Have liver disease,
- Have uncontrolled hypertension (>160 mmHg systolic and/or >100 mmHg diastolic),
Show all 29Show fewer
- Have unstable cardiovascular disease,
- Have a history of severe cardiovascular problems,
- Have decompensated heart failure,
- Have uncontrolled arrhythmias,
- Have severe pulmonary hypertension (mean pulmonary arterial pressure >55 mm Hg),
- Have severe and symptomatic aortic stenosis,
- Have acute myocarditis, endocarditis, or pericarditis,
- Have aortic dissection,
- Have Marfan syndrome,
- Have unrepaired aortic aneurysm,
- Have proliferative diabetic retinopathy,
- Have rapidly progressive terminal illness,
- Are unable to perform resistance exercise to due preexisting musculoskeletal conditions (e.g., joint pain, chronic injury or tendinopathy),
- Are under biguanide (metformin) treatment, but are taking for less than 3 months,
- Have taken drugs known to increase the risk of tendon disorders (e.g., tendinopathy and tendon rupture) within the last 6 months. These drugs include, but may not be limited to: fluoroquinolones, glucocorticoids, aromatase inhibitors, anabolic steroids, antiretrovirals, isotretinoin, cephalexin, rituximab, sitagliptin, cephalosporins, azithromycin, and sulfonamides.
- Are pregnant or trying to become pregnant during the study,
- Are prisoners,
- Are persons that require a legally authorized representative.
- Temporary exclusions include:
- Being subjected to recent surgeries for which resistance training is not recommended,
- Have symptomatic hernias,
- Have acute illness,
- Have recent fractures, or other injuries until resolved.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNM Exercise Physiology Lab
Albuquerque, New Mexico, 87131-0001
About this study
Official title: The Effect of Perceived Effort in Resistance Training on Glycemic Control and Psychological Responses in Individuals Living With Type 2 Diabetes Mellitus: a Randomized-controlled, Parallel Group, Clinical Trial
In this study the primary aims are to investigate the effect of resistance exercise training with different degrees of effort on glycemic control and psychological variables in individuals living with type 2 diabetes mellitus. As a secondary aim, investigate adherence and dropout rates and reasons for dropping out and adhering or not to the protocols.
Read the detailed description
Resistance exercise training can be both effective for the management of type 2 diabetes mellitus (T2DM) and appealing for individuals living with T2DM, and has been shown to be a viable exercise prescription option for this population. It has been suggested that the degree of effort is important for acute improvements in glucose metabolism and insulin sensitivity in individuals living with T2DM, although direct evidence of that is lacking. However, performing resistance exercise sets with a high degree of effort is associated with higher perceived exertion and discomfort, increased muscle soreness, negative perceptual responses, and higher neuromuscular fatigue and muscle damage. Taken together, these negative perceptual and physiological responses to resistance exercise sets performed with high degree of effort might negatively affect enjoyment, self-efficacy, and motivation during a resistance exercise session, ultimately reducing long-term adherence.
The primary aim of this study is to assess the effects resistance exercise training with different degrees of effort on glycemic control and psychological responses in individuals living with T2DM. Also, perceptual responses will be assessed to investigate how feelings experienced during resistance exercise training are altered relative to different degrees of effort. The hypothesis is that glycemic control will not be affected by the degree of effort, and improvements will be observed regardless of that. Also, it is hypothesized that the degree of effort will be associated with better psychological responses. The secondary aim of this study is to investigate and report adherence rate and reasons for adhering or not to the protocols. It is anticipated that adherence will be associated with the degree of effort and psychological responses experienced during training.
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- High-effort resistance exercise training, Low-effort resistance exercise training
- Keywords
- Resistance training, Degree of effort, Glycemic control, Continuous glucose monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-effort resistance exercise trainingBehavioural
Six sets per exercise, 8 repetitions per set.
Low-effort resistance exercise trainingBehavioural
Three sets per exercise, 4 repetitions per set.
| Study group | Role | What they receive |
|---|---|---|
| High-effort | Experimental | The high-effort protocol will entail performing 3 sets per exercise, 8 repetitions per set, ~2.5 seconds per repetition, with 120 seconds between sets and exercises. Receives: Behavioral: High-effort resistance exercise training |
| Low-effort | Experimental | The low-effort protocol will entail performing 6 sets per exercise, 4 repetitions per set, ~2.5 seconds per repetition, with 60 seconds between sets and exercises. Receives: Behavioral: Low-effort resistance exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose concentration
Average glucose concentration (measured in milligrams per deciliter of blood, with a continuous glucose monitoring device)
Measured: For 60 hours before the first training session and for 60 hours after the last (32nd) training session
Secondary outcomes (1)
Adherence to the resistance training protocols
Adherence rate assessed using the Kaplan-Meier method
Measured: From date of randomization until the date of first documented dropout from any cause, assessed up to 16 weeks (the end of the training period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start10 Sep 2024
- Primary completion5 Mar 2026
- Study completion5 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 Diabetes MellitusStudies 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
- Participants will undergo anthropometrics, familiarization, and strength test, and will be randomized to a high-effort, or a low-effort resistance training protocol, that will be carried out 2 days/week, for 16 weeks, and will be composed of 7 exercises (hex bar squat, seated chest press, leg press, lat pulldown, leg extension, shoulder press, leg curl, always in this order). Load will be set at 10-RM load (75% 1-RM). Participants will be instructed to perform the concentric (lifting) phase of the repetition as fast as they can (\~0.5 seconds), and to perform the eccentric phase in 2 seconds. Psychological responses (perceived exertion, enjoyment, feeling scale, discomfort, and self-efficacy) will be assessed. Anthropometrics will be repeated after training, and before and after the training period, glycemic control will be assessed via a continuous glucose monitoring device. The main outcomes will be compared between training interventions, pre-training data will used as comparator.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Flavio De Castro Magalhaes, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497842
- Sponsor's protocol ID
- HRRC#24-101
- Status last verified
- Sep 2026
- First submitted
- 28 Jun 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: For sharing the data generated the Open Science Framework (OSF) platform will be used. Before data sharing, all personal identifiers will be stripped from the data. Specifically, any direct identifiers (e.g., name, email addresses, phone and cell phone numbers), date identifiers (e.g., birthday, date of disease diagnosis, dates patients participated in data collection), location identifiers (e.g., personal or professional addresses, zip codes), links to external datasets identifiers (e.g., social media accounts) will be removed. Furthermore, participants will be represented by an identification string generated randomly (www.random.org/strings/), and their data will be inserted in the files in a random order, not associated with the order they were enrolled. Thus, data will be entirely de-identified before sharing, in order to protect sensitive personal information and privacy.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perceived Effort in Resistance Training on Glycemic Control and Psychological Responses in Individuals Living With Type 2 Diabetes Mellitus: a Randomized-controlled, Parallel Group, Clinical Trial
- ClinicalTrials.gov ID
- NCT06497842
- Acronym / sponsor ID
- HRRC#24-101
- Conditions
- Type2 Diabetes Mellitus
- Keywords
- Resistance training, Degree of effort, Glycemic control, Continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 5 Mar 2026 (actual)
- Study completion
- 5 Mar 2026 (actual)
- First posted
- 12 Jul 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.
In this study the primary aims are to investigate the effect of resistance exercise training with different degrees of effort on glycemic control and psychological variables in individuals living with type 2 diabetes mellitus. As a secondary aim, investigate adherence and dropout rates and reasons for dropping out and adhering or not to the protocols.
Detailed description
Resistance exercise training can be both effective for the management of type 2 diabetes mellitus (T2DM) and appealing for individuals living with T2DM, and has been shown to be a viable exercise prescription option for this population. It has been suggested that the degree of effort is important for acute improvements in glucose metabolism and insulin sensitivity in individuals living with T2DM, although direct evidence of that is lacking. However, performing resistance exercise sets with a high degree of effort is associated with higher perceived exertion and discomfort, increased muscle soreness, negative perceptual responses, and higher neuromuscular fatigue and muscle damage. Taken together, these negative perceptual and physiological responses to resistance exercise sets performed with high degree of effort might negatively affect enjoyment, self-efficacy, and motivation during a resistance exercise session, ultimately reducing long-term adherence.
The primary aim of this study is to assess the effects resistance exercise training with different degrees of effort on glycemic control and psychological responses in individuals living with T2DM. Also, perceptual responses will be assessed to investigate how feelings experienced during resistance exercise training are altered relative to different degrees of effort. The hypothesis is that glycemic control will not be affected by the degree of effort, and improvements will be observed regardless of that. Also, it is hypothesized that the degree of effort will be associated with better psychological responses. The secondary aim of this study is to investigate and report adherence rate and reasons for adhering or not to the protocols. It is anticipated that adherence will be associated with the degree of effort and psychological responses experienced during training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will undergo anthropometrics, familiarization, and strength test, and will be randomized to a high-effort, or a low-effort resistance training protocol, that will be carried out 2 days/week, for 16 weeks, and will be composed of 7 exercises (hex bar squat, seated chest press, leg press, lat pulldown, leg extension, shoulder press, leg curl, always in this order). Load will be set at 10-RM load (75% 1-RM). Participants will be instructed to perform the concentric (lifting) phase of the repetition as fast as they can (~0.5 seconds), and to perform the eccentric phase in 2 seconds. Psychological responses (perceived exertion, enjoyment, feeling scale, discomfort, and self-efficacy) will be assessed. Anthropometrics will be repeated after training, and before and after the training period, glycemic control will be assessed via a continuous glucose monitoring device. The main outcomes will be compared between training interventions, pre-training data will used as comparator.
| Arm | Type | Receives |
|---|---|---|
| High-effort | Experimental | Behavioral: High-effort resistance exercise trainingThe high-effort protocol will entail performing 3 sets per exercise, 8 repetitions per set, ~2.5 seconds per repetition, with 120 seconds between sets and exercises. |
| Low-effort | Experimental | Behavioral: Low-effort resistance exercise trainingThe low-effort protocol will entail performing 6 sets per exercise, 4 repetitions per set, ~2.5 seconds per repetition, with 60 seconds between sets and exercises. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Living with type 2 diabetes mellitus
Key exclusion criteria (29 listed)
- Have a significant cognitive impairment,
- Are non-ambulatory,
- Have lower extremity amputation,
- Have renal failure,
- Have liver disease,
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 |
|---|---|---|
| High-effort resistance exercise trainingSix sets per exercise, 8 repetitions per set. | Behavioural | High-effort |
| Low-effort resistance exercise trainingThree sets per exercise, 4 repetitions per set. | Behavioural | Low-effort |
Primary outcome
Glucose concentration
Time frame: For 60 hours before the first training session and for 60 hours after the last (32nd) training session
Average glucose concentration (measured in milligrams per deciliter of blood, with a continuous glucose monitoring device)
1 secondary outcome
Adherence to the resistance training protocols
Time frame: From date of randomization until the date of first documented dropout from any cause, assessed up to 16 weeks (the end of the training period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Yes. For sharing the data generated the Open Science Framework (OSF) platform will be used. Before data sharing, all personal identifiers will be stripped from the data. Specifically, any direct identifiers (e.g., name, email addresses, phone and cell phone numbers), date identifiers (e.g., birthday, date of disease diagnosis, dates patients participated in data collection), location identifiers (e.g., personal or professional addresses, zip codes), links to external datasets identifiers (e.g., social media accounts) will be removed. Furthermore, participants will be represented by an identification string generated randomly (www.random.org/strings/), and their data will be inserted in the files in a random order, not associated with the order they were enrolled. Thus, data will be entirely de-identified before sharing, in order to protect sensitive personal information and privacy.
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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.
Flavio De Castro Magalhaes, PhD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-effort resistance exercise training and Low-effort resistance exercise training in people with Type2 Diabetes Mellitus, run by University of New Mexico 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 1 inclusion and 29 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: finished, as of the sponsor's last update on 3 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose concentration (time frame: For 60 hours before the first training session and for 60 hours after the last (32nd) training session). 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 Sep 2026.