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Title: Effect of liraglutide on physical performance in type 2 diabetes (LIPER2): A randomised, double-blind, controlled trial
Authors: Wägner, Ana María 
Miranda Calderín, Guillermo 
Ugarte-Lopetegui, Miren Arantza
Marrero-Santiago, Héctor
Suárez-Castellano, Laura
Alberiche Ruano, Maria Del Pino 
Castillo-García, Nuria
López-Madrazo, María José
Alemán, Carolina
Martínez-Mancebo, Carla
López Ríos, Laura
Díez del Pino, Alicia 
Novoa Mogollón, Francisco 
UNESCO Clasification: 320502 Endocrinología
Keywords: Randomised controlled trial
Maximal oxygen consumption
Ventricular function
Diabetes, et al
Issue Date: 2016
Journal: Contemporary Clinical Trials Communications 
Abstract: 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.
ISSN: 2451-8654
DOI: 10.1016/j.conctc.2016.06.007
Source: Contemporary Clinical Trials Communications[ISSN 2451-8654],v. 4, p. 46-51, (Diciembre 2016)
Rights: by-nc-nd
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