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Unable to recruit due to COVID-19 pandemic
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acute BH4/Tetrahydrobiopterin treatment | Experimental | Oral supplement, Pill, 10 mg/kg of body weight |
|
| Placebo | Placebo Comparator | Oral supplement, Pill, Placebo pill with inert excipient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tetrahydrobiopterin | Drug | Oral, Single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mitochondrial function | PCr recovery kinetics | 4 hours |
| intracellular PO2 | Myoglobin oxygenation | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| systemic blood markers of oxidative stress | blood markers | 4 hours |
| Peripheral Blood flow | Exercise Blood flow by Doppler Ultrasound |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Applied Life Sciences | Amherst | Massachusetts | 01003 | United States |
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6 months post-publication
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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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D010661 | Phenylketonurias |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C003402 | sapropterin |
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| Placebo oral tablet |
| Drug |
Single dose |
|
| 4 hours |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020739 | Brain Diseases, Metabolic, Inborn |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000592 | Amino Acid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001519 | Behavior |