Investigating metabolic changes in blood and muscle in patients with intermittent claudication

Acute Local Metabolomic Alterations in Blood and Muscle Tissue in Intermittent Claudication

This study looks at changes in blood and muscle in people with intermittent claudication to see how these changes relate to their walking ability and to find new treatment options.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University of Tartu (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Tartu, Tartumaa)
• Trial ID: NCT05111379 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore acute local metabolomic changes in the ischemic limbs of patients diagnosed with intermittent claudication due to peripheral arterial occlusive disease. By comparing these alterations with the maximal walking distance of the patients, the study seeks to enhance understanding of the disease's pathophysiology. The findings may help identify novel therapeutic targets for more effective treatments in this high-risk population. The study includes both patients with the condition and healthy volunteers for comparison.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with lower extremity arterial disease at Fontaine Stage IIa.

Not a fit: Patients with more severe stages of the disease or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for patients suffering from intermittent claudication.

How similar studies have performed: While the specific approach of this study may be novel, similar studies investigating metabolomic changes in related conditions have shown promising results.

Eligibility criteria

Inclusion Criteria:

* LEAD group: Patients with diagnosis of lower extremity arterial disease (Fontaine IIa).
* Control group: Healthy volunteers with no leg symptoms and an ankle-brachial index (ABI) of 1.0-1.4.

Exclusion Criteria:

* Fontaine stages I or IIb-IV
* Exacerbation of limb ischaemia within the preceding 2 weeks;
* strong rest pain of any cause;
* age \<18 or \>80 years;
* fasting \< 6 hours;
* time since last use of tobacco products \< 6 hours;
* body mass index ≥ 35 kg/m2
* poor sonographic visibility of femoral artery;
* angina;
* cardiac arrhythmia at the time of presentation;
* presence of cardiac pacemaker;
* myocardial infarction within the preceding 3 months;
* stroke within the preceding 6 months;
* ongoing anticoagulant therapy;
* ongoing dual antiplatelet therapy;
* any revascularization within the preceding 3 month;
* marked heart failure (NYHA III-IV);
* blood pressure ≥ 180/110 mmHg;
* blood pressure \<100/70 mmHg;
* clinically significant heart valve disease;
* acute infectious disease;
* active malignancy or chemotherapy or disease-free \< 5 years;
* type I diabetes or insulin therapy;
* other clinically significant and untreated endocrine disorders;
* moderate to severe bronchial asthma (GINA 2016);
* severe chronic obstructive pulmonary disease (mMRC grade 3-4);
* acute (KDIGO 2012) or chronic renal disease (eGFR-EPI \<30mL/min/1.73 m2);
* acute or chronic liver disease;
* anemia (\<110 g/L);
* neuroinflammatory or neurodegenerative disease;
* active rheumatism;
* other diseases and factors that markedly hinder the subject's ability to walk during the treadmill exercise.
* For control group exclusively: history of lower extremity arterial disease / ABI \<1.0 or \>1.4.

Where this trial is running

Tartu, Tartumaa

• Tartu University Hospital — Tartu, Tartumaa, Estonia (RECRUITING)

Study contacts

• Principal investigator: Jaak Kals, MD, PhD — University of Tartu
• Study coordinator: Jaak Kals, MD, PhD

Conditions: Peripheral Arterial Occlusive Disease Fontaine Stage IIa, lower extremity arterial disease, peripheral artery disease, intermittent claudication, local, metabolism, metabolomics, arteriovenous gradients