Clinical trial NCT06288399: Prevalence and Economic Burden of Obesity-related Comorbidities in the Gulf Region: A Retrospective, Observational Study
Official title: Prevalence and Economic Burden of Obesity-related Comorbidities in the Gulf Region: A Retrospective, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-03-01
Enrollment: 1322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with diagnosis of obesity and obesity-related comorbidities

Brief summary: The aim of this study is to assess the annual prevalence of ORCs among adult people with obesity in the real-world clinical setting across the Gulf region. In addition, the study will describe the annual HCRU and associated costs of obesity and ORCs, describe the demographics and clinical characteristics of adult people with obesity, as well as estimate the annual incidence and point prevalence of the ORCs among adult people with obesity.


Eligibility criteria: Inclusion Criteria:

1. Local national (male or female) of Arab ethnicity, age above or equal to 18 years at index date
2. Primary or secondary diagnosis of obesity (BMI above or equal to 30 kg/m2) at index date
3. Minimum of 1 visit with BMI recorded between months 1 and 6 following index date, and minimum of 1 visit with BMI recorded between months 7 and 12 following index date.

There should be a minimum time gap of 3 months between the BMI records and the BMI must be above or equal 30 kg/m2 at each visit. If there are multiple visits during the 12-month observation period, then a mean BMI above or equal 30 kg/m2 must be maintained during the observation period.

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having collected data of the participants in this study already.
2. Participation in an interventional trial during the 12-month observation period
3. Conditions associated with unintentional weight change
4. Participants who underwent bariatric surgery within 18 months prior to the index date
5. Participants with non-ambulatory disability diagnosis

Primary outcomes:
measure: Proportion of Obesity Related Comorbidities (ORC, existing/newly diagnosed) among adult people with obesity (BMI above or equal to 30 kg/m2) over a period of 12 months across the Gulf region in primary and secondary hospitals as well as obesity clinics
timeFrame: 12-month observation period from the index date (Day 1) to Month 12 after the index date (+12 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Farwaniya
country: Kuwait
facility: Farwaniya Hospital
city: Hadiya
country: Kuwait
facility: Al-Adan Hospital
city: Kuwait City
country: Kuwait
facility: Al-Amiri Hospital
city: Muscat
country: Oman
facility: National Diabetes and Endocrine Center
city: Samail
country: Oman
facility: Samail Polyclinic
city: Doha
country: Qatar
facility: Hamad General Hospital
city: Doha
country: Qatar
facility: PHCC
Study officials:
References: