Effort During Resistance Training in Type 2 Diabetes

NCT06497842 | Active Not Recruiting DMC

• 1 other identifier: HRRC#24-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes Mellitus

Keywords

Resistance training; Degree of effort; Glycemic control; Continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Adherence to the resistance training protocols

  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)

Study Arms (2)

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

High-effort resistance exercise training BEHAVIORAL

Six sets per exercise, 8 repetitions per set.

High-effort

Low-effort resistance exercise training BEHAVIORAL

Three sets per exercise, 4 repetitions per set.

Low-effort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Living with type 2 diabetes mellitus

You may not qualify if:

• 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,

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

UNM Exercise Physiology Lab

Albuquerque, New Mexico, 87131-0001, United States

Location

Study Officials

• Flavio De Castro Magalhaes, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data and statistical analysis will be performed by a researcher blinded to groups and participants' identities.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 12, 2024
• Study Start: September 10, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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

Locations

US (1)