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O2 Transport and Utilization in Health and Lung Disease

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ClinicalTrials.gov Identifier: NCT04014712
Recruitment Status : Not yet recruiting
First Posted : July 10, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
University of Massachusetts, Amherst

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.

Condition or disease Intervention/treatment Phase
COPD Tetrahydrobiopterin Deficiency Oxidative Stress Drug: Tetrahydrobiopterin Drug: Placebo oral tablet Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Role of Nitric Oxide Coupling in Muscle Dysfunction With COPD
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022


Arm Intervention/treatment
Experimental: acute BH4/Tetrahydrobiopterin treatment
Oral supplement, Pill, 10 mg/kg of body weight
Drug: Tetrahydrobiopterin
Oral, Single dose

Placebo Comparator: Placebo
Oral supplement, Pill, Placebo pill with inert excipient
Drug: Placebo oral tablet
Single dose




Primary Outcome Measures :
  1. Mitochondrial function [ Time Frame: 4 hours ]
    PCr recovery kinetics

  2. intracellular PO2 [ Time Frame: 4 hours ]
    Myoglobin oxygenation


Secondary Outcome Measures :
  1. systemic blood markers of oxidative stress [ Time Frame: 4 hours ]
    blood markers

  2. Peripheral Blood flow [ Time Frame: 4 hours ]
    Exercise Blood flow by Doppler Ultrasound



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04014712


Locations
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United States, Massachusetts
Institute of Applied Life Sciences Not yet recruiting
Amherst, Massachusetts, United States, 01003
Contact: Gwenael Layec, PhD    413-345-2739    glayec@umass.edu   
Contact: Mary Emma Searles       msearles@umass.edu   
Sponsors and Collaborators
University of Massachusetts, Amherst

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Responsible Party: University of Massachusetts, Amherst
ClinicalTrials.gov Identifier: NCT04014712     History of Changes
Other Study ID Numbers: 2018-4815
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: 6 months post-publication
Access Criteria: Within 6 months after the data have been published, and upon written request, a limited, de-identified, anonymized dataset will be created pursuant to the Data use Agreement.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Massachusetts, Amherst:
BH4
Exercise
Mitochondria
Vascular function

Additional relevant MeSH terms:
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Phenylketonurias
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases