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Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)NCT06697756

Resistance Training for the Improvement of Glycemic Control in Prediabetes

A study testing High-effort resistance exercise training and Low-effort resistance exercise training in people with Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), run by University of New Mexico at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this research is to study the effects of resistance exercise training with different degrees of effort on your glucose responses (what we call glycemic control) and psychological responses. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
High-effort resistance exercise training and Low-effort resistance exercise training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
19 Nov 2024to 28 Feb 2028
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age between 18 and 75 years;
  • presence of prediabetes (fasting glycemia between 100 and 125 mg/dL or glycated hemoglobin [A1c] between 5.7 and 6.4%).

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

Other trials in United States

About this study

Official title: The Effect of Manipulating the Perception of Effort During Resistance Exercise Training on Glycemic Control and Psychological Responses in Individuals Living With Prediabetes: a Randomized-controlled Trial

The purpose of this research is to study the effects of resistance exercise training with different degrees of effort on your glucose responses (what we call glycemic control) and psychological responses.

Read the detailed description

Type 2 diabetes is a disease where peripheral insulin resistance associated with pancreatic beta-cell dysfunction leads to chronically elevated blood glucose levels. Type 2 diabetes is preceded by prediabetes, a condition where blood glucose levels are higher than normal, but not enough to be considered type 2 diabetes. One in 3 Americans 18 years-old or over is living with prediabetes and their risk of developing type 2 diabetes is ~50%. Importantly, prediabetes is a treatable condition, it has been shown that exercise interventions are more effective than metformin (the most commonly prescribed hypoglycemic oral mediation) for the improvement in glucose control in individuals living with prediabetes.

Although regular exercise is highly recommended for the management and improvement of glycemic control for individuals living with prediabetes, adherence to exercise interventions is lower than those without prediabetes. The reasons individuals do not engage in regular exercise are multifaceted, but often relate to low self-efficacy (self-perception of the ability to accomplish something), and perceiving exercise as uncomfortable. In fact, those factors have been shown to predict exercise behavior in individuals living with prediabetes and type 2 diabetes. Thus, strategies aiming at improving feelings and perceptions during exercise, while retaining the positive improvement on glucose metabolism, can potentially increase long-term exercise adherence for individuals living with prediabetes.

Aerobic exercise is usually the default exercise prescribed for individuals living with prediabetes. However, as most individuals living with prediabetes are overweight and sedentary, even a brisk walk can be difficult, uncomfortable or painful, and resistance exercise training can be a more attractive and easier form of exercise. Moreover, there is vast literature showing that resistance exercise training improves glycemic control in individuals living with prediabetes and type 2 diabetes. Importantly, resistance exercise training has been shown to reduce prediabetes prevalence in individuals living with prediabetes. Altogether, resistance exercise training can be both effective for the prevention of type 2 diabetes and appealing for individuals living with prediabetes, and has been shown to be a viable exercise prescription option for this population. Not surprisingly, resistance exercise training prescription for individuals living with prediabetes and type 2 diabetes is widely recommended by international guidelines.

Resistance exercise training prescription entails the manipulation of many variables. These include exercise type (single- or multi-joint) and order, load, number of sets per exercise, repetitions per set, repetition duration (aka tempo), and resting interval between sets. There are also variables that are derived from the above, such as total volume-load (load x sets x reps), and session density (total volume-load divided by session duration). Appropriate manipulation of these variables is regarded as important for targeting specific adaptations. More recently, attention has also been directed to the degree of effort during resistance exercise training sets as a potentially important variable that can be manipulated to affect adaptative outcomes. In fact, it has been suggested that the degree of effort is important for improvements in glucose metabolism and insulin sensitivity in individuals living with type 2 diabetes, 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. Individuals living with prediabetes might be even more susceptible to these negative responses, because as stated earlier, their physical activity levels are particularly low, and they identify lack of motivation and low self-efficacy as barriers for being more physically active.

Therefore, resistance exercise training prescriptions should to be tailored to meet not only the glycemic control needs of individuals living with prediabetes, but also their motivation and self-perceived capacity to engage in, and long-term adhere to exercise. Thus, 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 prediabetes. Although the degree of effort has been suggested to play an important role in the beneficial effects of resistance exercise on glucose and insulin responses in individuals living with type 2 diabetes, this has not been tested directly, nor it is known if this also applies to individuals living with prediabetes. 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 low degree of effort will be associated with better psychological responses. As a secondary aim, adherence rate and reasons for adhering or not to the protocols will be thoroughly investigated and reported. It is anticipated that better adherence will be associated with the low degree of effort and psychological responses experienced during training.

Being tested
High-effort resistance exercise training, Low-effort resistance exercise training
Keywords
resistance training, glycemic control
Medical subject headings
Prediabetic State, Insulin Resistance, Glucose Intolerance

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 groups in NCT06697756
Study groupRoleWhat they receive
High-effortExperimentalThe 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-effortExperimentalThe 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.

  1. 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)
  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.

  1. First posted20 Nov 2024
  2. Study start19 Nov 2024
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion28 Feb 2028 (estimated)

Resources

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
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06697756
Sponsor's protocol ID
2409157184
Status last verified
Dec 2025
First submitted
18 Nov 2024
Last updated
10 Dec 2025
Results posted
No
Data monitoring committee
No
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.

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 Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), 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 2 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: under way, not looking for participants, as of the sponsor's last update on 10 Dec 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?

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 10 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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