Actively Recruiting
The Sarcopenia Study
Led by University of Leicester · Updated on 2023-12-19
80
Participants Needed
1
Research Sites
142 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this cross-sectional study is to investigate the prevalence of sarcopenia in patients with Heart Failure. The main question it aims to answer is: Whether there is a difference in the prevalence of sarcopenia across the spectrum of HFpEF (Heart failure with preserved ejection fraction) and HFrEF (heart failure with reduced ejection fraction). This is an observational study. The participant population involves patients with heart failure with preserved ejection fraction and heart failure with reduced ejection fraction. Healthy volunteers will be recruited as controls in addition to adults with asymptomatic Type 2 Diabetes. Participants will undergo the following: 1. Skeletal muscle mass, quality and body composition assessments using magnetic resonance imaging (MRI) and bioelectrical impedance analysis (BIA) 2. Skeletal muscle strength assessments (Dynamometer, FysioMeter, handgrip strength) 3. Skeletal muscle energetics assessment (31p-Spectroscopy pre/post-exercise recovery) Researchers will compare Heart failure groups with healthy controls and adults with asymptomatic type 2 Diabetes to see if there are significant differences in the strength, mass and quality of skeletal muscle.
CONDITIONS
Official Title
The Sarcopenia Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Heart failure patients with established diagnosis of HFpEF (EF > 50%) and clinically stable for 3 months or more, age 65 or older
- Heart failure patients with established diagnosis of HFpEF or HFrEF (EF < 40%) and clinically stable for 3 months or more, age 65 or older
- Healthy volunteers aged over 18 who can provide written informed consent
- Adults aged 18 to 75 years with stable asymptomatic Type 2 Diabetes diagnosed by formal records or glucose tests
- Willingness to provide written consent for participation in the study
You will not qualify if you...
- Any absolute contraindication to MRI
- Inability to walk or perform the 6-Minute Walk Test
- Having neuromuscular disorders such as motor neurone disease, multiple sclerosis, skeletal muscle myopathies, or myositis
- Regular or intermittent use of oral corticosteroids
- Untreated hyperthyroidism or hypothyroidism
- Heart failure-related hospitalizations within the last 3 months
- Healthy volunteers with previous or current signs of heart failure or risk factors like hypertension, diabetes, or coronary artery disease
- Asymptomatic Type 2 Diabetes patients with angina, limiting dyspnea greater than NYHA II, major atherosclerotic disease, atrial fibrillation or flutter, moderate to severe valvular heart disease, history of heart failure or cardiomyopathy, Type 1 diabetes, low fasting C-peptide levels, stage III-V renal disease (eGFR ≤ 30 ml/min/1.73m2), or MRI contraindications
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, United Kingdom, LE1 5WW
Actively Recruiting
Research Team
S
Sally Utton
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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