EXercise Capacity and TRAinability in Type 2 Diabetes (EXTRA-T2D)

NCT05860842 | Unknown

• 1 other identifier: 2023-04
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

Type 2 Diabetes (T2D) is a condition characterized by acelerated aging and is associated to multiple comorbidities, and physical fragility and disabilitiy, all of which reduce life expectancy and quality of life. Physical exercise has been demonstrated to have metabolic and cardiovascular benefits in T2D. Also, lack of exercise and sedentary behavior are major predictors of cardiovascular morbidity and mortality and all-cause mortality. Some evidence suggests that individuals with T2D have a reduced exercise capacity and exercise tollerance compared to non-diabetic individuals.The reasons behind such difference are not thoroughly explored, but may be connected to acute and chronic effects of hyperglycemia. Reduced trainability might be a marker of early aging and physical disalbility. This study aims to define respiratory, cardiovascular, neuromuscular, inflammatory, hormonal and metabolic determinants of trainability in persons with T2D. Results will help to answer the question whether it is the low trainability that reduces exercise capacity or it is the low exercise participation that determines a low exercise capacity.

Conditions

Type 2 Diabetes; Exercise; Aging

Outcome Measures

Primary Outcomes (1)

• Change in peak power output (PPO)

  Exercise capacity will be measured as the PPO achieved at the end of the ramp incremental test, registered to the nearest second. After 2 min of baseline pedaling at 20 W, the power output will be increased by 1 W/s (20 W/min) until task failure (i.e., the inability to maintain pedaling cadence at 70 rpm for more than 10 s). Participants will be asked to maintain this cadence throughout any ramp test to eliminate the potentially confounding effect of cadence on responses measured with a metabolic cart (Quark PFT, Cosmed, Rome, Italy). Trainability will be measured for single participants as the percentage difference from the average PPO of the incremental tests at T1 and the average PPO of the two incremental tests at T0 (ΔPPO). The ΔPPO of both T2D and control groups will then be calculated and compared by averaging ΔPPO of single participants in each group.

  3 time points over 12 months: at baseline, after training (month 6) and after follow-up (month 12);

Study Arms (1)

exercise training

EXPERIMENTAL

6-month supervised exercise training program

Other: exercise

Interventions

exercise OTHER

Six months of supervised combined exercise training program, consisting of 2 sessions/wk of 75 min each, followed by a six-month period of follow-up. Each session will comprise a 5-min warm-up, 30-min endurance exercise, 30-min resistance exercise, 5-min flexibility and 5-min cool-down.

exercise training

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being below the recommended targets for MVPA and sedentary time (both healthy and diabetic individuals)
• HbA1c \<7.5%
• dietary or pharmacological treatment excluding insulin
• disease duration \>1 year
• free from chronic complications
• absence of CVD and renal disease

You may not qualify if:

• Smoking
• Any condition impairing ventilatory, cardiorespiratory and neuromuscular function, limiting or contraindicating PA, affecting conduct of the trial, reducing lifespan, and/or affecting the safety of intervention.

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• Università degli studi di Roma Foro Italico: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Giuseppe Pugliese, MD, PhD

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Pugliese, MD, PhD

CONTACT

+390633775440; giuseppe.pugliese@uniroma1.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 16, 2023
• Study Start: February 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: September 30, 2025
• Last Updated: November 29, 2023

Record last verified: 2023-11