Uttam Thakur1, Anil Bhansali2, Rajesh Gupta1, Ashu Rastogi3. 1. Department of Gastro-intestinal Surgery, PGIMER, Chandigarh, Chandigarh, India. 2. Department of Endocrinology, PGIMER, Chandigarh, Room-1011, Nehru Hospital Extension Block, Chandigarh, 160012, India. 3. Department of Endocrinology, PGIMER, Chandigarh, Room-1011, Nehru Hospital Extension Block, Chandigarh, 160012, India. ashuendo@gmail.com.
Abstract
PURPOSE: Both laparoscopic sleeve gastrectomy (LSG) and liraglutide cause a significant weight loss. We evaluated the effect of liraglutide in comparison with placebo on total weight loss (TWL) and excess body weight loss (EWL) and when added in initial weight loss period after LSG in obese individuals. MATERIAL AND METHODS:Participants with BMI > 30kg/m2 undergoing LSG were randomised to receive either liraglutide (subcutaneous) in increasing does of 0.6 mg/day until maximum tolerated dose of 3.0 mg (L-L group) or placebo (L-P group) from 6 weeks post-operative until 6 months. Weight, BMI, %TWL, %EWL, HbA1c, fasting plasma glucose, HOMA-IR, resolution of type 2 diabetes mellitus, hypertension, dyslipidaemia, sleep apnea and quality of life were evaluated. Primary end point was %TWL and % EWL at post-operative 6 months. RESULTS:Thirty participants underwentLSG, and 23 were randomised to receive liraglutide (n = 12) or placebo (n = 11).The mean dose of liraglutide in L-L group was 1.41 ± 0.49 mg/day. Patients in L-L group had %TWL of 28.2 ± 5.7 and %EWL of 58.7 ± 14.3 as compared with 23.2 ± 6.2 (p = 0.116) and 44.5 ± 8.6 (p = 0.043) in L-P group at 24 weeks, respectively. BMI decreased by 11.7 ± 3.5 in L-L group compared with 9.5 ± 4.0 in L-P group (p = 0.287). All patients with diabetes or pre-diabetes had resolution of dysglycemia in the L-L group as compared with 50% in L-P group. However, there was no significant difference in resolution of other obesity-related comorbidities between two groups at 24-week follow-up. CONCLUSION: Liraglutide added early after LSG significantly augments weight loss from LSG in obese individuals. TRIAL REGISTRATION: The study protocol was registered at clinical trials.gov.in with NCT: 04325581.
RCT Entities:
PURPOSE: Both laparoscopic sleeve gastrectomy (LSG) and liraglutide cause a significant weight loss. We evaluated the effect of liraglutide in comparison with placebo on total weight loss (TWL) and excess body weight loss (EWL) and when added in initial weight loss period after LSG in obese individuals. MATERIAL AND METHODS:Participants with BMI > 30 kg/m2 undergoing LSG were randomised to receive either liraglutide (subcutaneous) in increasing does of 0.6 mg/day until maximum tolerated dose of 3.0 mg (L-L group) or placebo (L-P group) from 6 weeks post-operative until 6 months. Weight, BMI, %TWL, %EWL, HbA1c, fasting plasma glucose, HOMA-IR, resolution of type 2 diabetes mellitus, hypertension, dyslipidaemia, sleep apnea and quality of life were evaluated. Primary end point was %TWL and % EWL at post-operative 6 months. RESULTS: Thirty participants underwent LSG, and 23 were randomised to receive liraglutide (n = 12) or placebo (n = 11).The mean dose of liraglutide in L-L group was 1.41 ± 0.49 mg/day. Patients in L-L group had %TWL of 28.2 ± 5.7 and %EWL of 58.7 ± 14.3 as compared with 23.2 ± 6.2 (p = 0.116) and 44.5 ± 8.6 (p = 0.043) in L-P group at 24 weeks, respectively. BMI decreased by 11.7 ± 3.5 in L-L group compared with 9.5 ± 4.0 in L-P group (p = 0.287). All patients with diabetes or pre-diabetes had resolution of dysglycemia in the L-L group as compared with 50% in L-P group. However, there was no significant difference in resolution of other obesity-related comorbidities between two groups at 24-week follow-up. CONCLUSION: Liraglutide added early after LSG significantly augments weight loss from LSG in obese individuals. TRIAL REGISTRATION: The study protocol was registered at clinical trials.gov.in with NCT: 04325581.
Authors: Joshuan J Barboza; Mariella R Huamán; Beatriz Melgar; Carlos Diaz-Arocutipa; German Valenzuela-Rodriguez; Adrian V Hernandez Journal: J Clin Med Date: 2022-05-25 Impact factor: 4.964