Prevalence and Economic Burden of Obesity-related Comorbidities in the Gulf Region: A Retrospective, Observational Study

Obesity Clinical Trial

Official title:

Prevalence and Economic Burden of Obesity-related Comorbidities in the Gulf Region: A Retrospective, Observational Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06288399
• Other study ID #: DAS-7688
• Secondary ID: U1111-1292-7248
• Status: Enrolling by invitation
• Start date: December 21, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1322
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Financial Stress
• Obesity

Intervention

Other:
• No treatment given
No treatment given

Locations

Country	Name	City	State
Kuwait	Farwaniya Hospital	Farwaniya
Kuwait	Al-Adan Hospital	Hadiya
Kuwait	Novo Nordisk Investigational Site	Kuwait
Kuwait	Al-Amiri Hospital	Kuwait City
Oman	National Diabetes and Endocrine Center	Muscat
Oman	Samail Polyclinic	Samail
Qatar	Hamad General Hospital	Doha
Qatar	PHCC	Doha

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Kuwait,  Oman,  Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage (and 95% CI); ORC: Dyslipidaemia, Hypertensive diseases, Type 2 diabetes mellitus, Non-alcoholic fatty liver disease, Coronary artery disease	12-month observation period from the index date (Day 1) to Month 12 after the index date (+12 months)