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PreDiabetesNCT06208189

Is the Degree of Perceived Effort During Resistance Exercise Important for Improvements in Blood Glucose

A study testing High-effort session and Low-effort session in people with PreDiabetes and Type 2 Diabetes Mellitus, 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 goal of this clinical trial is to compare the degree of effort during a resistance exercise session on blood glucose levels in individuals with prediabetes or type 2 diabetes mellitus. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
PreDiabetes, Type 2 Diabetes Mellitus
What is being tested?
High-effort session and Low-effort session
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15 participants
Where
1 siteUnited States
Study dates
12 Jun 2024to 30 Oct 2026
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%) or T2DM (fasting glycemia 126 mg/dL or above or A1c 6.5% or above).

Who cannot join

  • renal failure,
  • liver disease,
  • uncontrolled hypertension (equal or greater than 160 mmHg systolic and/or equal or greater than 100 mmHg diastolic),
  • history of severe cardiovascular problems,
  • in case of oral hypoglycemic drugs usage, being on them for less than 6 months,
  • inability to perform resistance exercise,
Show all 11Show fewer
  • being pregnant or trying to become pregnant during the course of the study,
  • use of oral contraceptives,
  • prisoners,
  • persons requiring a legally authorized representative,
  • non-English speakers.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UNM Exercise Physiology Lab

    Albuquerque, New Mexico, 87131-0001

Other trials in United States

About this study

Official title: The Effect of Effort During a Resistance Exercise Session on Glycemic Control in Individuals With Prediabetes or Type 2 Diabetes Mellitus: a Randomized-controlled Trial

The goal of this clinical trial is to compare the degree of effort during a resistance exercise session on blood glucose levels in individuals with prediabetes or type 2 diabetes mellitus. The main questions it aims to answer are:

  • Do individuals with prediabetes or type 2 diabetes mellitus need to perform resistance exercise with a high degree of effort for their blood glucose to improve?
  • How do they feel (their enjoyment, discomfort) after the sessions with different degrees of effort?
Read more

Participants will perform 3 situations separated by at least 4 days, after being familiarized with all exercises and procedures:

  • One control day, when they will not exercise;
  • A high-effort resistance exercise session;
  • A low-effort resistance exercise session Researchers will measure blood glucose levels and psychological responses after these situations to see if the effort was important for the improvement of their blood glucose and how effort affected the way they felt after each situation.
Being tested
High-effort session, Low-effort session, Control
Keywords
strength exercise, degree of effort, glycemic control, continuous glucose monitoring, prediabetes, type 2 diabetes mellitus
Medical subject headings
Prediabetic State, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-effort sessionBehavioural

    Participants will perform 3 sets per exercise (total of 21 sets) with as many repetitions they can each set. We anticipate participants will perform ~10 repetitions per set in this session, with a total tempo of ~2.5 seconds per rep, averaging ~25 seconds per set. Resting period between exercises and sets will be 120 seconds. This will lead to a total session time of ~50 min. Their glycemic control will be evaluated during the following ~48 hours.

  • Low-effort sessionBehavioural

    Participants will perform 6 sets per exercise (total of 42 sets) but perform half of the anticipated number of repetitions of the HIGH session (i.e., 5 reps). Repetition tempo at ~2.5 seconds will result in ~12.5 seconds per set. Resting period between exercises and sets will be 60 seconds. This prescription will also lead to a total session time of ~50 min. Thus, both the HIGH and LOW session will have similar total volume-load and session density, but differ in perceived effort after each set. Their glycemic control will be evaluated during the following ~48 hours.

  • ControlBehavioural

    The control session all procedures will be identical to the HIGH session, with the exception of performing the resistance exercises. However, to simulate all other procedures participants will follow all instructions, be positioned on the equipment for the same amount of time as the HIGH session, but will not perform any repetition. Interval between fake sets and exercises will be 120 seconds. Their glycemic control will be evaluated during the following ~48 hours.

Study groups in NCT06208189
Study groupRoleWhat they receive
high-effort sessionExperimentalParticipants will perform sets with as many repetitions they can each set.
Receives: Behavioral: High-effort session
low-effort sessionExperimentalParticipants will perform sets with half of the anticipated number of repetitions of the high-effort session.
Receives: Behavioral: Low-effort session
Control sessionSham comparatorThe control session all procedures will be identical to the high-effort session.
Receives: Behavioral: Control

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 48 hours during each situation (arm) of the study

  2. Glucose concentration

    Average glucose concentration (measured in milligrams per deciliter of blood, with a continuous glucose monitoring device)

    Measured: For 6 hours during the morning (6 am - 12 pm) of each situation (arm) of the study

  3. Glucose concentration

    Average glucose concentration (measured in milligrams per deciliter of blood, with a continuous glucose monitoring device)

    Measured: For 6 hours during the afternoon (12 pm - 6 pm) of each situation (arm) of the study

  4. Glucose concentration

    Average glucose concentration (measured in milligrams per deciliter of blood, with a continuous glucose monitoring device)

    Measured: For 6 hours during the evening (6 pm - 12 am) of each situation (arm) of the study

  5. Glucose concentration

    Average glucose concentration (measured in milligrams per deciliter of blood, with a continuous glucose monitoring device)

    Measured: For 6 hours during the nocturnal period (12 am - 6 am) of each situation (arm) of the study

  6. Time in range

    Time of glucose concentration between 70 and 180 mg/dL (measured in minutes)

    Measured: For 48 hours during each situation (arm) of the study

  7. Time in range

    Time of glucose concentration between 70 and 180 mg/dL (measured in minutes)

    Measured: For 6 hours during the morning (6 am - 12 pm) of each situation (arm) of the study

  8. Time in range

    Time of glucose concentration between 70 and 180 mg/dL (measured in minutes)

    Measured: For 6 hours during the afternoon (12 pm - 6 pm) of each situation (arm) of the study

  9. Time in range

    Time of glucose concentration between 70 and 180 mg/dL (measured in minutes)

    Measured: For 6 hours during the evening (6 pm - 12 am) of each situation (arm) of the study

  10. Time in range

    Time of glucose concentration between 70 and 180 mg/dL (measured in minutes)

    Measured: For 6 hours during the nocturnal period (12 am - 6 am) of each situation (arm) of the study

  11. Prevalence of hyperglycemia

    Time of glucose concentrations >180 mg/dL (measured in minutes)

    Measured: For 48 hours during each situation (arm) of the study

  12. Prevalence of hyperglycemia

    Time of glucose concentrations >180 mg/dL (measured in minutes)

    Measured: For 6 hours during the morning (6 am - 12 pm) of each situation (arm) of the study

  13. Prevalence of hyperglycemia

    Time of glucose concentrations >180 mg/dL (measured in minutes)

    Measured: For 6 hours during the afternoon (12 pm - 6 pm) of each situation (arm) of the study

  14. Prevalence of hyperglycemia

    Time of glucose concentrations >180 mg/dL (measured in minutes)

    Measured: For 6 hours during the evening (6 pm - 12 am) of each situation (arm) of the study

  15. Prevalence of hyperglycemia

    Time of glucose concentrations >180 mg/dL (measured in minutes)

    Measured: For 6 hours during the nocturnal period (12 am - 6 am) of each situation (arm) of the study

  16. Prevalence of hypoglycemia

    Time of glucose concentrations <70 mg/dL (measured in minutes)

    Measured: For 48 hours during each situation (arm) of the study

  17. Prevalence of hypoglycemia

    Time of glucose concentrations <70 mg/dL (measured in minutes)

    Measured: For 6 hours during the morning (6 am - 12 pm) of each situation (arm) of the study

  18. Prevalence of hypoglycemia

    Time of glucose concentrations <70 mg/dL (measured in minutes)

    Measured: For 6 hours during the afternoon (12 pm - 6 pm) of each situation (arm) of the study

  19. Prevalence of hypoglycemia

    Time of glucose concentrations <70 mg/dL (measured in minutes)

    Measured: For 6 hours during the evening (6 pm - 12 am) of each situation (arm) of the study

  20. Prevalence of hypoglycemia

    Time of glucose concentrations <70 mg/dL (measured in minutes)

    Measured: For 6 hours during the nocturnal period (12 am - 6 am) of each situation (arm) of the study

Secondary outcomes (6)
  1. Resistance Training Intensity by the Omni Perceived Exertion Scale

    Discrete scale from 0 to 10, where higher values mean more perceived exertion.

    Measured: After each set of each exercise performed.

  2. Feeling scale

    Discrete scale from -5 to +5, where higher values mean more positive feelings.

    Measured: Before and immediately after the resistance exercise sessions.

  3. Physical Activity Enjoyment Scale

    Scale composed of 18 items, with scores from 1 to 7 each (total score from 18 to 126). After analysis, higher scores mean higher enjoyment.

    Measured: Immediately after the resistance exercise sessions.

  4. Self-efficacy scale

    Scale composed of 8 questions, with discrete options from 0 to 100%. Higher scores mean higher self-efficacy.

    Measured: Immediately after the resistance exercise sessions.

  5. Rating of Discomfort scale

    Discrete scale from 0 to 100, where higher scores mean more discomfort.

    Measured: Before and 5 minutes after the resistance exercise sessions.

  6. Session rating of perceived exertion

    Discrete scale from 0 to 10, where higher values mean more perceived exertion.

    Measured: 5 minutes after the resistance exercise sessions.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2024
  2. Study start12 Jun 2024
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion30 Oct 2026 (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
Crossover
Model description
Randomized controlled, crossover, 3-way, clinical trial, following the SPIRIT and the TIDieR guidelines. After being considered eligible and agreeing to participate, participants will undergo anthropometrics assessment, familiarization sessions, and strength assessment before randomly carrying out 3 experimental (2 exercise and one control) periods, each composed of a total of \~48 hours, separated by at least 4 days. During the experimental periods diet will be strictly controlled and provided to the participants. Glycemic control will be assessed by a continuous glucose monitoring system throughout the experimental periods. The exercise sessions will be identical regarding total volume-load and session density, but proximity to failure in each set will be manipulated so effort will be different between the sessions. The control session will be identical in all procedures as the exercise sessions except that participants will remain sedentary.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06208189
Sponsor's protocol ID
2310089095
Status last verified
Sep 2026
First submitted
28 Dec 2023
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: For sharing the data generated we will use the Open Science Framework (OSF) platform. 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 ID string generated randomly (https://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.

Publications

  • Ramirez M, Gebauer M, Mermier C, Little JP, Lin L, Palley G, Hsiao YY, Mota Alvidrez RI, Mang ZA, Amorim FT, Tricoli V, De Castro Magalhaes F. The Effect of Effort During a Resistance Exercise Session on Glycemic Control in Individuals Living With Prediabetes or Type 2 Diabetes: Protocol for a Crossover Randomized Controlled Trial. JMIR Res Protoc. 2024 Nov 5;13:e63598. doi: 10.2196/63598.

    PubMed 39499920

Questions about this trial

What is this clinical trial studying?

A study testing High-effort session and Low-effort session in people with PreDiabetes and Type 2 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 2 inclusion and 11 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 4 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. 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?

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 48 hours during each situation (arm) of the study). The study lists 20 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 NCT06208189, 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 4 Sep 2026.

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