NCT06057623Completed
Neuromuscular Fatigue and Exercise Capacity in Patients With Type 2 Diabetes Mellitus and HFpEF
Type 2 Diabetes Mellitus Influence on Patients With Heart Failure With Preserved Ejection Fraction in Neuromuscular Fatigue and Exercise Capacity
Source: ClinicalTrials.gov · Last updated 30 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 21 (actual)
- First submitted
- 21 Jun 2023
- Start date
- 15 Jun 2023
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Diseases
- Heart failure, Type 2 diabetes
- NCT number
- NCT06057623
What you commit to
- Study type: Observational
- Participants enrolled: 21
- From 15 Jun 2023 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 5\. Changes in drug therapy in the previous three months because of clinical instability
Other illness
- 2\. Significant additional valvular heart diseases
- 3\. Unstable heart failure
- 8\. Presence of diagnosis and signs and symptoms of diabetic neuropathy (intensified perception of pain, burning or cold sensation, tingling, pins, and needles, hypo-hypersensitivity to touch)
Lab values
- 1\. Unstable diabetes documented by HbA1c ≥ 9%
Other
- 4\. Presence of a pacemaker or implanted defibrillator (AICD)
- 6\. Body mass index (BMI) \> 35 and \< 20 kg/m2
- 7\. Orthopedic limitations that prevent the exercise
- 9\. Severe deconditioning (patient is confined to home) or vigorous physical activity (sports or similar activity, estimated as more than two hours/day of vigorous exercise)
Who the study is looking for
- Have a diagnosis of heart failure with preserved ejection fraction (\>50%, NYHA class II - III)
- Have an age between 65 and 80 years
- Be males
- Have at least one hospitalization for heart failure during the previous 10 years
- Have a diagnosis of diabetes for no more than 10 years at the time of cardiology examination
Age in the registry: 65 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituti Clinici Scientifici Maugeri IRCCS Coordinator of this site? Confirm its status | Lumezzane | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.