O2 Transport and Utilization in Health and Lung Disease

Brief Title

O2 Transport and Utilization in Health and Lung Disease

Official Title

Role of Nitric Oxide Coupling in Muscle Dysfunction With COPD

Brief Summary

      Skeletal muscle dysfunction is a frequent and clinically relevant systemic manifestation of
      Chronic Pulmonary Obstructive Disease (COPD), which is still poorly understood. Therefore,
      the focus of this study is on the role of a deficit in tetrahydrobiopterin and nitric oxide
      synthase uncoupling induced by chronic oxidative stress on metabolic and vascular
      abnormalities in skeletal muscle of patients suffering from COPD.
    

Detailed Description

      The purpose of this study is to assess the efficacy of supplementation with
      tetrahydrobiopterin (BH4) for improving vascular and muscle function in patients with COPD
      and healthy controls.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Mitochondrial function

Secondary Outcome

 systemic blood markers of oxidative stress

Condition

COPD

Intervention

Tetrahydrobiopterin

Study Arms / Comparison Groups

 acute BH4/Tetrahydrobiopterin treatment
Description:  Oral supplement, Pill, 10 mg/kg of body weight

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

30

Start Date

August 2019

Completion Date

August 2022

Primary Completion Date

August 2022

Eligibility Criteria

        Inclusion Criteria:

          -  All subjects must be between the age of 18 and 85 years;

          -  For the COPD cohort, patients with a diagnosis of stable COPD (i.e., those not
             experiencing an acute exacerbation of symptoms) and spirometric evidence of airway
             obstruction (FEV1 <80% predicted, FEV/FVC<0.70);

          -  Ability to perform motor tests;

          -  Ability to provide informed consent

        Exclusion Criteria:

          -  uncontrolled hypertension;

          -  hyperlipidemia;

          -  recent exacerbation;

          -  Major cardiovascular event procedure (<3 months);

          -  Pregnancy

          -  known significant hepatic, renal disease, active substance abuse

          -  contraindication to MRI, claustrophobia
      

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04014712

Organization ID

2018-4815


Responsible Party

Sponsor

Study Sponsor

University of Massachusetts, Amherst


Study Sponsor

, , 


Verification Date

July 2019