The Relationship Between Peripheral Arterial Disease and Mitochondrial Respiratory Capacity

August 4, 2016 updated by: Norwegian University of Science and Technology

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • Department of Circulation and Medical Imaging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with arterial insufficience at 1 of three levels, either asymptotic, intermittent claudication or critical limb ischemia; and healthy persons in a control group

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1st level of arterial insufficiency
asymptomatic PAD patients
2nd level of arterial insufficiency
Intermittent claudication patients
3rd level of arterial insufficiency
Critical limb ischemia patients
No arterial insufficiency
Healthy individuals (control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mitochondrial respiratory capacity
Time Frame: 1 hour
measured in oxygen glux in pmol.s-1.mg-1, using mitochondrial respirometry on an Oxygraph-2k (Oroboros Instruments, Austria).
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

Investigators

  • Study Director: Øyvind Rognmo, Norwegian University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

April 30, 2015

First Submitted That Met QC Criteria

April 30, 2015

First Posted (Estimate)

May 5, 2015

Study Record Updates

Last Update Posted (Estimate)

August 5, 2016

Last Update Submitted That Met QC Criteria

August 4, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/204

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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