Obesity & Overweight
Conditions
Brief summary
The study is multicenter and observational, consisting of a cross-sectional phase (V0) in which data will be collected from patients who are offered drug therapy, and a prospective longitudinal phase in which only patients who agree to start drug therapy for obesity will be involved
Detailed description
The primary objective is to identify the proportion and medical history, social, clinical, laboratory, and behavioral characteristics of patients who accept a prescription for a drug for overweight and obesity compared to the total number of patients to whom it is proposed. The secondary objective will only concern patients who decide to start anti-obesity drug therapy. In this population, the efficacy and tolerance of these molecules and patient adherence to drug therapy in a real-life setting will be evaluated. These parameters will be monitored with regular follow-ups for up to 5 years after the start of therapy or 12 months after discontinuation of the drug. The study population will consist of patients aged ≥ 12 years, the age at which certain therapies are approved for obesity (Liraglutide and Semaglutide in particular). Patients will be recruited from among those who meet all inclusion and exclusion criteria and are followed up at the listed healthcare units or by the listed private practitioners.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age ≥ 12 years * Therapeutic indication for taking one of the following drugs for the treatment of obesity: Orlistat, Naltrexone/Bupropion (Mysimba®), Liraglutide (Saxenda®), Semaglutide (Wegovy®), Tirzepatide (Mounjaro®)
Exclusion criteria
- Type 1 and type 2 diabetes mellitus \- Secondary forms of obesity: * Hypothalamic obesity (both monogenic and acquired forms); * Syndromic obesity (e.g., Prader-Willi, Alstrom, Bardet Biedl, etc.); * Endocrinopathies associated with obesity (Cushing's syndrome, uncompensated hypothyroidism)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary objective is to identify the proportion and medical history, social, clinical, laboratory, and behavioral characteristics of patients who accept a prescription for a drug for overweight and obesity compared to the total number of patients | 10 years | The primary objective is to identify the proportion and medical history, social, clinical, laboratory, and behavioral characteristics of patients who accept a prescription for a drug for overweight and obesity compared to the total number of patients to whom it is proposed. These parameters will be monitored with regular follow-ups for up to 5 years after the start of therapy or 12 months after discontinuation of the drug. Descriptive statistics will be used to verify the primary objective. The demographic and clinical characteristics of patients will be reported as frequencies and percentages for categorical variables and as mean ± standard deviation or median and range for continuous variables. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The secondary objective will only concern patients who decide to start anti-obesity drug therapy. In this population, the efficacy and tolerance of these molecules and patient adherence to drug therapy in a real-life setting will be evaluated | 10 years | These parameters will be monitored with regular follow-ups for up to 5 years after the start of therapy or 12 months after discontinuation of the drug. Descriptive statistics, t-tests for paired data, Wilcoxon signed-rank tests, McNemar tests, t-tests, Kruskal-Wallis tests, chi-square tests, Fisher's exact tests, logistic regression models, conditional logistic regression, and linear mixed-effects models will be used to verify the secondary objectives. The p-value will be considered significant when less than 0.05 for two-tailed tests. Statistical analysis will be performed using IBM SPSS Statistics for Windows, Version 29.0 (Armonk, NY: IBM Corp) software. |
| descriptive statistics, paired t-tests, Wilcoxon signed-rank tests, McNemar tests, t-tests, Kruskal-Wallis tests, chi-square tests, Fisher's exact tests, logistic regression models, conditional logistic regression, linear mixed-effects models | 10 years | — |
Countries
Italy
Contacts
CONTACTUberto Pagotto, MD
PRINCIPAL_INVESTIGATORUberto Pagotto, MD
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Outcome results
None listed