The Relationship Between Peripheral Arterial Disease and Mitochondrial Respiratory Capacity

Intermittent Claudication Clinical Trial

Official title:

The Relationship Between Peripheral Arterial Disease and Mitochondrial Respiratory Capacity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02434783
• Other study ID #: 2015/204
• Status: Completed
• Phase: N/A
• First received: April 30, 2015
• Last updated: August 4, 2016
• Start date: May 2015
• Est. completion date: April 2016

Study information

• Verified date: August 2016
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial Summary

Current evidence cannot explain the clinical features of peripheral arterial disease only from the principle of reduced blood flow. Explanations have therefore in addition been linked to mitochondrial dysfunction of skeletal muscles.

This study will elucidate whether there is a relation between clinical variables of the different levels of arterial insufficiency in peripheral arterial disease and mitochondrial respiratory capacity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Asymptotic peripheral arterial disease (Ankle-brachial index < 0.9), intermittent claudication (Ankle-brachial index 0.4 - 0.9), or critical limb ischemia (Ankle-brachial index < 0.4)

Exclusion Criteria:

• Diagnosed with intermittent claudication secondary to vascular insufficiency

• Warfarin or heparin usage

• Underwent a vascular intervention in the last 6 months

• Active cancer, renal- or liver disease

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Locations

Country	Name	City	State
Norway	Department of Circulation and Medical Imaging	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mitochondrial respiratory capacity	measured in oxygen glux in pmol.s-1.mg-1, using mitochondrial respirometry on an Oxygraph-2k (Oroboros Instruments, Austria).	1 hour	No