Effort During Resistance Training in Type 2 Diabetes | NCT06497842

Studies
Effort During Resistance Training in Type 2 Diabetes

NCT06497842

Sponsor

University of New Mexico

Status

Active, not recruiting

Last Update Posted

Jun 10, 2026Actual

Enrollment

48Estimated

Phase

Not Applicable

Conditions

Type2 Diabetes Mellitus

Interventions

High-effort resistance exercise training
Low-effort resistance exercise training

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 10, 2024Actual

Primary Completion Date

Jul 30, 2026Estimated

Completion Date

Jul 30, 2026Estimated

First Submitted Date

Jun 28, 2024

First Submission Date that Met QC Criteria

Jul 9, 2024

First Posted Date

Jul 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2026

Last Update Posted Date

Jun 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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.	Behavioral: Low-effort resistance exercise training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High-effort resistance exercise training	Behavioral	Six sets per exercise, 8 repetitions per set.	High-effort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glucose concentration	Average glucose concentration (measured in milligrams per deciliter of blood, with a continuous glucose monitoring device)	For 60 hours before the first training session and for 60 hours after the last (32nd) training session

Secondary Outcomes

Measure	Description	Time Frame
Adherence to the resistance training protocols	Adherence rate assessed using the Kaplan-Meier method	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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Living with type 2 diabetes mellitus

Exclusion Criteria:

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),
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Flavio De Castro Magalhaes, PhD	Assistant Professor	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
UNM Exercise Physiology Lab		Albuquerque	New Mexico	87131-0001	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

The anticipated date for data sharing will be 6 months after publication of data or 18 months after award end date, whatever happens first.

Access Criteria

Open access

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	May 22, 2024	Jun 27, 2024	ICF_000.pdf

Intervention 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.