Carla López-Padrós1, Neus Salord1,2,3, Carolina Alves4, Núria Vilarrasa4,5,6, Merce Gasa1,2,3, Rosa Planas7, Monica Montsserrat5, M Nuria Virgili4,5,8, Carmen Rodríguez1, Sandra Pérez-Ramos1, Esther López-Cadena9, M Inmaculata Ramos10, Jordi Dorca1,2,8, Carmen Monasterio1,2,3. 1. Multidisciplinary Sleep Unit, Department of Respiratory Medicine, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Spain. 2. Section of Respiratory Medicine, Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Spain. 3. Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Spain. 4. Section of Endocrinology, Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Spain. 5. Department of Endocrinology and Nutrition Department, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Spain. 6. CIBER de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM-CIBER), Spain. 7. Department of Rehabilitation, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Spain. 8. Department of Medicine, Universitat de Barcelona, Campus Bellvitge, L'Hospitalet de Llobregat, Spain. 9. Respiratory Medicine Department, Hospital Universitari Sagrat Cor, Barcelona, Spain. 10. LINDE Healthcare, Spain.
Abstract
STUDY OBJECTIVES: To determine whether an intensive weight-loss program (IWLP) is effective for reducing weight, the severity of obstructive sleep apnea (OSA), and metabolic variables in patients with obesity and severe OSA undergoing continuous positive airway pressure treatment. METHODS: Forty-two patients were randomized to the control (CG, n = 20) or the intervention group (IG, n = 22), who followed a 12-month IWLP. The primary outcome was a reduction in the apnea-hypopnea index (AHI) as measured at 3 and 12 months by full polysomnography. Metabolic variables, blood pressure, body fat composition by bioimpedance, carotid intima media thickness, and visceral fat by computed tomography were also assessed. RESULTS:Mean age was 49 (6.7) years, body mass index 35 (2.7) kg/m², and AHI 69 (20) events/h. Weight reduction was higher for the IG than the CG at 3 and 12 months, -10.5 versus -2.3 kg (P < .001), and -8.2 versus -0.1 kg (P < .001), respectively, as was loss of visceral fat at 12 months. AHI decreased more in the IG at 3 months (-23.72 versus -9 events/h) but the difference was not significant at 12 months, though 28% of patients from the IG had an AHI < 30 events/h compared to none in the CG (P = .046). At 12 months, the IG showed a reduction in C-reactive protein (P = .013), glycated hemoglobin (P = .031) and an increase in high density lipoprotein cholesterol (P = .027). CONCLUSIONS: An IWLP in patients with obesity and severe OSA is effective for reducing weight and OSA severity. It also results in an improvement in lipid profiles, glycemic control, and inflammatory markers. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Title: Effectiveness of an Intensive Weight Loss Program for Obstructive Sleep Apnea Syndrome (OSAS) Treatment; Identifier: NCT02832414; URL: https://clinicaltrials.gov/ct2/show/record/NCT02832414.
RCT Entities:
STUDY OBJECTIVES: To determine whether an intensive weight-loss program (IWLP) is effective for reducing weight, the severity of obstructive sleep apnea (OSA), and metabolic variables in patients with obesity and severe OSA undergoing continuous positive airway pressure treatment. METHODS: Forty-two patients were randomized to the control (CG, n = 20) or the intervention group (IG, n = 22), who followed a 12-month IWLP. The primary outcome was a reduction in the apnea-hypopnea index (AHI) as measured at 3 and 12 months by full polysomnography. Metabolic variables, blood pressure, body fat composition by bioimpedance, carotid intima media thickness, and visceral fat by computed tomography were also assessed. RESULTS: Mean age was 49 (6.7) years, body mass index 35 (2.7) kg/m², and AHI 69 (20) events/h. Weight reduction was higher for the IG than the CG at 3 and 12 months, -10.5 versus -2.3 kg (P < .001), and -8.2 versus -0.1 kg (P < .001), respectively, as was loss of visceral fat at 12 months. AHI decreased more in the IG at 3 months (-23.72 versus -9 events/h) but the difference was not significant at 12 months, though 28% of patients from the IG had an AHI < 30 events/h compared to none in the CG (P = .046). At 12 months, the IG showed a reduction in C-reactive protein (P = .013), glycated hemoglobin (P = .031) and an increase in high density lipoprotein cholesterol (P = .027). CONCLUSIONS: An IWLP in patients with obesity and severe OSA is effective for reducing weight and OSA severity. It also results in an improvement in lipid profiles, glycemic control, and inflammatory markers. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Title: Effectiveness of an Intensive Weight Loss Program for Obstructive Sleep Apnea Syndrome (OSAS) Treatment; Identifier: NCT02832414; URL: https://clinicaltrials.gov/ct2/show/record/NCT02832414.
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