Effect of liraglutide on physical performance in type 2 diabetes (LIPER2): A randomised, double-blind, controlled trial
| Autor: | Héctor Marrero-Santiago, María del Pino Alberiche-Ruano, F.J. Nóvoa-Mogollón, Miren Arantza Ugarte-Lopetegui, Alicia Díez del Pino, María José López-Madrazo, Ana M. Wägner, Guillermo Miranda-Calderín, Carla Martínez-Mancebo, Carolina Alemán, Nuria Castillo-García, Laura Suárez-Castellano, Laura López-Ríos |
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| Rok vydání: | 2016 |
| Předmět: |
Pregnancy test
medicine.medical_specialty VO2 máx maximal oxygen consumption Ergometry GLP1 glucagon-like peptide 1 LIPER2 LIraglutide and physical PERformance in type 2 diabetes 030209 endocrinology & metabolism GLP1-agonist Type 2 diabetes 030204 cardiovascular system & hematology Article law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Internal medicine Diabetes mellitus Maximal oxygen consumption medicine Ventricular function Randomised controlled trial Pharmacology lcsh:R5-920 Liraglutide business.industry Diabetes T2D Type 2 diabetes mellitus General Medicine DPP4 dipeptidyl peptidase 4 medicine.disease Surgery Metformin Blood pressure Cardiology Liver function lcsh:Medicine (General) business medicine.drug |
| Zdroj: | Contemporary Clinical Trials Communications Contemporary Clinical Trials Communications, Vol 4, Iss C, Pp 46-51 (2016) |
| ISSN: | 2451-8654 |
| DOI: | 10.1016/j.conctc.2016.06.007 |
| Popis: | Preclinical studies and small clinical trials suggest that glucagon-like peptide 1 (GLP1) may have a positive effect on ventricular function. Liraglutide is a GLP1-analogue used in the treatment of type 2 diabetes. LIPER2 is a phase IV, randomised, double-blind, placebo-controlled, parallel-design trial, assessing the effect of 6 months’ liraglutide 1.8 mg/d on measures of cardiac function and physical performance in patients with type 2 diabetes. A total of 30 patients with type 2 diabetes will be included, if their HbA1c is between 7 and 10% while on oral agents (including metformin if tolerated and not contraindicated), a maximum of 2 intermediate or long-acting insulin injections per day or a combination of both. After their baseline examinations, patients are randomised to receive a daily subcutaneous liraglutide or placebo injection (titrated to 1.8 mg/d if tolerated) for 6 months. The primary end-point is the maximal oxygen consumption during cycle ergometry at the end of the study period. Other end-points include distance covered during a 6-min walk test, left ventricular ejection fraction and other measures of ventricular systolic and diastolic functions assessed by echocardiography, heart rate, blood pressure, pro-brain natriuretic peptide, C-reactive protein, HbA1c, lipids, apolipoprotein B, body weight and waist girth. Safety end-points include adverse event reporting, blood count, kidney and liver function, amylase, lipase, electrolytes, calcitonin, CA19.9 and pregnancy test for fertile women. At the time of this report, recruitment is still ongoing. Results are expected to be reported in December 2016. |
| Databáze: | OpenAIRE |
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