The acute effect of beta-guanidinopropionic acid versus creatine or placebo in healthy men (ABC Trial): study protocol for a randomized controlled trial
Karamat FA, Horjus DL, Haan YC, van der Woude L, Oudman I, van Montfrans GA, Clark JF, Brewster LM
Trials · 6 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- Nederlandse Organisatie voor Wetenschappelijk Onderzoek
Según 1 financiador declarado y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2015-02-21 · Trials · vol. 16 · número 1 · pág. 56
- Editorial
- Springer Science+Business Media
- Citado
- 7 citas · más que el 79% de estudios similares · 0.9× el promedio de su campo
- Referencias
- 30 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY
- Áreas de investigación
- Blood Pressure and Hypertension Studies · Muscle metabolism and nutrition · Sodium Intake and Health
- Palabras clave
- beta-guanidinopropionic acid, creatine, creatine kinase inhibition, resistant hypertension, blood pressure, tolerability, oral supplementation, creatine kinase, antihypertensive drugs, pulse wave velocity, augmentation index, central blood pressure, healthy men
- MeSH
- humans, hypertension, guanidines, creatine, propionates, creatine kinase, electrocardiography, clinical protocols, double-blind method, no-observed-adverse-effect level, adolescent, adult, middle aged, male
8 autores
- Fares A. Karamat🇳🇱 · autor de correspondenciaAmsterdam UMC Location University of Amsterdam; University of Amsterdam
- Deborah L. Horjus🇳🇱Amsterdam UMC Location University of Amsterdam; University of Amsterdam
- Yentl C. Haan🇳🇱Amsterdam UMC Location University of Amsterdam; University of Amsterdam
- Lisa van der Woude🇳🇱Amsterdam UMC Location University of Amsterdam; University of Amsterdam
- Inge Oudman🇳🇱Amsterdam UMC Location University of Amsterdam; University of Amsterdam
- Gert A. van Montfrans🇳🇱Amsterdam UMC Location University of Amsterdam; University of Amsterdam
- Joseph F. Clark🇺🇸Cincinnati Children's Hospital Medical Center
- Lizzy M. Brewster🇳🇱Amsterdam UMC Location University of Amsterdam; University of Amsterdam
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Despite adequate treatment, up to 30% of treated antihypertensive patients with primary, uncomplicated hypertension remain uncontrolled. We proposed that high intracellular activity of the ATP regenerating enzyme creatine kinase (CK) increases pressor responses and hypertension risk. In line with this, we found that plasma CK activity after rest, a surrogate measure of tissue activity, is the main predictor of blood pressure levels and failure of antihypertensive therapy in the general population. In addition, the creatine analog and competitive oral creatine kinase inhibitor beta-guanidinopropionic acid effectively and safely reduced blood pressure in the spontaneously hypertensive rat. However, to our knowledge there are no human data on the safety of oral supplementation with this substance. Therefore, we will assess the tolerability of beta-guanidinopropionic acid in men, compared to creatine and placebo.
Methods/design
This is a randomized, active and placebo controlled, triple blind, double dummy, single center clinical intervention trial in 24 healthy male volunteers, 18 to 50 years old, recruited in the Netherlands. The intervention consists of one week of daily oral administration of beta-guanidinopropionic acid 100 mg, creatine 5 gram, or placebo. The primary outcome is the tolerability of beta-guanidinopropionic acid as a descriptive measure, in an intent-to-treat analysis. Other outcomes include the placebo-adjusted differences with baseline in biochemical and hemodynamic parameters, including plasma markers of muscle tissue damage, urine sodium excretion, resting sitting systolic and diastolic brachial blood pressure, supine systolic and diastolic central blood pressure, pulse wave velocity and augmentation index, heart rate, cardiac contractility, cardiac output, and total peripheral resistance.
Discussion
There is an unfulfilled need for new conservative options to treat resistant hypertension. This study will provide first-in-men data on creatine kinase inhibition as a potential new class of antihypertensive drugs.
Trial registration
The Netherlands National Trial Register Trialregister.nl (identifier NTR 4444) , registered 9 March 2014.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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