Clinical Trials Logo

Clinical Trial Summary

Introduction: According to the National Health and Nutrition Examination Survey 2009-2010, 78 million American adults are obese. Bariatric surgery can provide for a sustained long-term weight loss and the metabolic change caused by the surgery seems to be the main cause of this loss. Cross-sectional, prospective and experimental studies, carried out during the post-operative period of Roux-en-Y Gastric Bypass surgery (RYGBP) have shown an increase of over 200% in energy expenditure after meals Diet-induced Thermogenesis (DIT), a specific component of energy expenditure) when compared with obese patients. However, despite this metabolic improvement, 20-50% of the patients can suffer weight regain about 2 years after surgery. So one question whether such metabolic benefits remain active following post-operative weight regain, or if the disappearance or decrease of these metabolic benefits may be seen as causes of this weight regain.

Objective:To evaluate whether there are DIT differences between patients who maintained weight loss and those who regained weight in the late postoperative (postop) period of RYGBP and those who continue with preoperative (preop) obesity.


Clinical Trial Description

Methods: This cross-sectional study evaluated three female groups: 1) Postop RYGBP patients operated at least 2 years previously, with healthy weight (at least 50% loss of excess weight) - HW group ; 2) Clinically severe obese patients (BMI > 40 kg/m2, without co-morbidities or > 35 kg/m2 with co-morbidities) - OB group; 3) Post-op RYGBP WR patients (at least 10% above post-op minimum weight and less than 50% loss of preop excess weight) - WR group. All patients, from a private practice in Brasilia, were given indirect calorimetry examinations (GERATHERM RESPIRATORY®) measuring resting metabolic rate (RMR), respiratory exchange rate (RER) and DIT and collected urine during 24 hours for analysis. Immediately after RMR measurement, a solid mixed meal was served (270 kcal: 62% carbohydrate, 12% protein and 26% lipid). Remove? After ten minutes, successive PP energy expenditure measurements were taken (after some minutes, viz): 10-20, 20-30, 30-40, 60-70, 70-80, 80-90, 110-120, 120- 130, 130-140, 160-170 and 170-180, accompanying a 3-hour measurement period. DIT, calculated for each interval, followed this equation: DIT = PP Metabolic rate (MR) time interval - RMR. Correct? Mean areas under the curve (AUC) of all groups and baseline time measurements were compared using the analysis of variance test (ANOVA). Between-group longitudinal changes were tested using a mixed-effects model analysis of variance for repeated measures. Showing a p-value < 0.05, a Bonferroni correction was used. AUC was calculated by trapezoidal rule, considering significant a value of p <0.05.

Results: 45 patients participated (HW 21, OB 13, WR 11). Mean group age was 37.00 ± 6.98 years , 38.72 ± 7.01 years, and 37.88 ± 6.39 years, respectively. I changed the sequence to match the original. RER values increased significantly in all groups from baseline until final measurements. Metabolic rate (MR) adjusted for body weight (BW-adjusted MR (MR/kg)?) was not significant in the OB group at any PP moment compared to baseline. The HW and WR groups showed significant increase until final measurements. Mean AUC values for RER and RMR in absolute terms did not differ between groups (p = 0.3111 and p = 0.1131, respectively). (Two p values for how many groups ? 2 or 3?) Mean AUC values for BW-adjusted MR (kcal/kg)? differed between groups, where the average AUC value was significantly greater in the HW group than in the WR and the OB groups (p <0.0001 for both). Mean AUC value for BW-adjusted MR in the WR group was not significantly different from the OB group (p = 0.6369). ;


Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


NCT number NCT02422212
Study type Interventional
Source Gastrocirurgia, Brazil
Contact
Status Completed
Phase N/A
Start date January 2014
Completion date April 2015

See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2