Markers of excess weight, weight loss and weight regain in candidates for surgical treatment of obesity

Not Applicable

Completed

• Conditions: Obesity (Class II to III); Nutritional, Metabolic, Endocrine; Obesity

• Registration Number: ISRCTN59323751
• Lead Sponsor: Champalimaud Research & Clinical Centre, Champalimaud Centre for the Unknown

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33558894/ (added 13/08/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-06-07
• Study Start: 2020-07-06
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 212

Inclusion Criteria

Consecutive adult patients with obesity at three Portuguese tertiary care outpatient centers specialized in the surgical treatment of obesity, namely Hospital do Espírito Santo de Évora, Hospital de São Bernardo de Setúbal, and Centro Hospitalar Universitário de São João for bariatric surgery, following the criteria defined in the Portuguese National Health Service:
1. Body mass index (BMI) greater than 40 kg/m2 with or without associated comorbidities or greater than 35 Kg/m2 in the presence of at least 1 comorbidity (type 2 diabetes mellitus, dyslipidemia, obstructive sleep apnea syndrome, obese hypoventilation syndrome, arterial hypertension or osteoarticular degenerative pathology, with marked functional limitation).
2. Age between 18 and 65 years
3. Failure of non-surgical interventions for weight reduction, for at least one year, obesity that is not secondary to an identified endocrine disease
4. Ability to understand the surgical procedure and to adhere to a long-term follow-up program
5. Absence of psychiatric disorders, absence of alcohol or drug dependence
6. Balanced relationship between operative risk and clinical risk

Exclusion Criteria

1. Active acute respiratory infection
2. Active neurological or psychiatric disease
3. Active gastrointestinal, hepatic or pancreatic disease
4. Illicit substance use or alcohol abuse
5. Illiteracy or otherwise not understanding instructions for the study
6. Prior major gastrointestinal surgery
7. Intra-gastric balloon
8. History of food allergies
9. Pregnancy or breastfeeding

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Primary response (dependent) variable:<br> Weight change from baseline [%WL = (weight lost/baseline weight)*100] assessed up to 18 months after surgery<br><br> Main explanatory (independent) variables:<br> 1. Mean intensity and pleasantness ratings given to four concentrations of sucrose (sweet) as assessed with general labeled magnitude scales (gLMS) at baseline up to 18 months after surgery<br> 2. Hedonic hunger assessed with the Power of Food Scale assessed at baseline and up to 18 months after surgery<br> 3. Addiction-like feeding behavior assessed with the Yale Food Addiction Scale assessed up to 18 months after surgery<br>