O2 Transport and Utilization in Health and Lung Disease

University of Massachusetts, Amherst

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Conditions

COPD Tetrahydrobiopterin Deficiency Oxidative Stress

Interventions

TetrahydrobiopterinDRUG

Oral, Single dose

Placebo oral tabletDRUG

Single dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Institute of Applied Life Sciences

Amherst, Massachusetts, United States

Outcomes

Primary Outcomes

Mitochondrial function

PCr recovery kinetics

Time frame: 4 hours

intracellular PO2

Myoglobin oxygenation

Time frame: 4 hours

Secondary Outcomes

systemic blood markers of oxidative stress

blood markers

Time frame: 4 hours

Peripheral Blood flow

Exercise Blood flow by Doppler Ultrasound

Time frame: 4 hours

Data from ClinicalTrials.gov

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