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Neuromuscular Fatigue and Exercise Capacity in Patients With Type 2 Diabetes Mellitus and HFpEF

NCT06057623 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 21

Last updated 2025-07-30

No results posted yet for this study

Summary

An important feature of patients with HFpEF is impaired exercise tolerance, resulting in worsening and reduced quality of life. Studies in the literature on patients with HFpEF suggest that the limited transport of oxygen to the muscles can be one factor leading to the early development of fatigue during physical activity and reduced effort tolerance. A recent study also shows that patients with HFpEF have an increased susceptibility to both central and peripheral fatigue, suggesting that neuromuscular fatigue may be one of the main mechanisms limiting exercise in this population.

Type 2 diabetes mellitus (T2DM), which affects 90-95% of diabetic patients, is a comorbidity of particular interest in heart failure (HF). In T2DM, as in HF, some observed an altered energy metabolism of the muscle and a shift in the type of muscle fibers. Hyperglycemia influences neuromuscular function and appeared to be one of the major causes of oxidative stress by affecting the intrinsic properties of the muscle (mitochondrial activity and function, myofilaments) related to the expression of force. The impact of diabetes on neuromuscular function is also linked to long-term complications such as diabetic peripheral neuropathy involving impairment of motor nerve conduction and vascular complications. This opens up a rather complex picture suggesting that T2DM in patients with HF could contribute to a further decline in muscle strength by further reducing the aerobic capacity of these patients.

It seems, there are currently no studies in the literature evaluating how much the coexistence of T2DM impacts neuromuscular fatigue and strength in patients with HF. Thus, the primary aim of this study will be to evaluate the differences in central and peripheral neuromuscular fatigue - determined by a submaximal exercise protocol with intermittent isometric contractions - in two groups of patients with heart failure with preserved ejection fraction with or without type 2 diabetes mellitus. Secondary outcomes will be related to the investigation of the differences in NO-mediated vascular function induced by a single passive movement of the leg, in the energy cost of walking, and in muscle oxygenation between the two groups.

Conditions

  • Diabetes Mellitus, Type 2
  • Heart Failure Preserved Ejection Fraction

Interventions

OTHER

Evaluation of central and peripheral neuromuscular fatigue

To define peripheral and central component of fatigue, the investigators will test, before, during and after the fatigue task, the force produced during a Maximal Voluntary Contraction (MVC) and the force produced by the electrically evoked Resting Twitch (RT) produced, at rest, 5 seconds after the MVC.

Sponsors & Collaborators

  • Istituti Clinici Scientifici Maugeri SpA

    lead OTHER

Principal Investigators

  • Mara Paneroni, PhD · Istituti Clinici Scientifici Maugeri

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-15
Primary Completion
2024-12-31
Completion
2025-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06057623 on ClinicalTrials.gov