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Effect of liraglutide on physical performance in type 2 diabetes: Results of a randomized,double-blind,controlled trial (LIPER2)
Authors:A.M. Wägner  G. Miranda-Calderín  M.A. Ugarte-Lopetegui  H. Marrero-Santiago  L. Suárez-Castellano  M.J. López-Madrazo  M.P. Alberiche-Ruano  N. Abselam Ahmed  C. Alemán  A. Castellot-Martín  A. Díez del Pino  F.J. Nóvoa-Mogollón
Affiliation:1. Materno-Infantil de Gran Canaria, Av Marítima s/n, 35016 Las Palmas de Gran Canaria, Spain;2. Instituto Universitario de Investigaciones Biomédicas y Sanitarias (IUIBS), Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain;3. Physical Medicine and Rehabilitation Department, Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Av Marítima s/n, 35016 Las Palmas de Gran Canaria, Spain;4. Cardiology Department, Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Av Marítima s/n, 35016 Las Palmas de Gran Canaria, Spain;5. Gastroenterology Department, Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Av Marítima s/n, 35016 Las Palmas de Gran Canaria, Spain;6. Hospital Pharmacy, Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Av Marítima s/n, 35016 Las Palmas de Gran Canaria, Spain
Abstract:AimsTo assess the effect of the GLP-1 analogue liraglutide on measures of cardiac function and physical performance in patients with type 2 diabetes (T2D).MethodsIn this phase-IV randomized double-blind placebo-controlled parallel-group clinical trial at a tertiary hospital, T2D patients with HbA1c levels of 7–10% with oral agents and/or intermediate-/long-acting insulin were allocated (computer-generated randomization, ratio 1:1) to either liraglutide 1.8 mg/day or a placebo for 6 months. The primary endpoint was maximum oxygen consumption (VO2max) during cycle ergometry, while other procedures included a 6-min walk test, echocardiography, anthropometry and blood tests. Safety endpoints were also monitored, and an intention-to-treat analysis was performed.ResultsA total of 24 patients (15 women) aged 52 (11.7) years, with diabetes duration of 8.7 (5.8) years, BMI 34.98 (6.2) kg/m2 and HbA1c 8.2% (0.68%), were randomized to liraglutide 1.8 mg daily or placebo. There were no differences in VO2max [17.98 (4.8) vs. 15.90 (4.96) mL/kg/min; P > 0.10], VE/VCO2 slope [30.18 (4.8) vs. 32 (4.49)], left ventricular ejection fraction or 6-min walk test [530.7 (86) vs. 503.9 (84) m] at 6 months. HbA1c was lower (6.7% vs. 7.7%; P = 0.005), with a trend towards lower maximum systolic blood pressure during ergometry [171.7 (24.4) vs. 192.5 (25.6); P = 0.052] in the liraglutide group at the end of the study. There were no severe adverse events.ConclusionIn this trial, liraglutide improved glycaemic control in T2D, but had no significant effects on either physical performance or myocardial function.
Keywords:Corresponding author at: S. Endocrinología y Nutrición, Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Av Marítima s/n, 35016 Las Palmas de Gran Canaria, Spain  GLP-1  glucagon-like peptide-1  LIPER2  (effect of) liraglutide on physical performance in type 2 diabetes  ITT  intention to treat  PP  per-protocol  maximum oxygen consumption  SBP  systolic blood pressure  DBP  diastolic blood pressure  RER  respiratory exchange ratio  ventilatory equivalent for oxygen at maximum oxygen consumption  VE/VCO2AT  ventilatory equivalent for carbon dioxide at the anaerobic threshold  Diabetes  Ergometry  GLP-1 agonist  Maximum oxygen consumption  Randomized controlled trial  Ventricular function
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