Resistance Training for the Improvement of Glycemic Control in Prediabetes

NCT06697756 | Active Not Recruiting

• 1 other identifier: 2409157184
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)

Keywords

resistance training; glycemic control

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:

• 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%).

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, United States

Location

MeSH Terms

Conditions

Prediabetic State; Insulin Resistance; Glucose Intolerance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Hyperglycemia

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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

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: November 18, 2024
• First Posted: November 20, 2024
• Study Start: November 19, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• 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)