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

Completed

• Conditions: Obesity
• Interventions: Other: No treatment given

• Registration Number: NCT06288399
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-21
• Study First Submitted: 2024-02-23
• Study First Submitted QC: 2024-02-23
• Study First Posted: 2024-03-01
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1322

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obesity Group	No treatment given	Adults with diagnosis of obesity and obesity-related comorbidities

Primary Outcome Measures

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

Trial Locations

Locations (7)

Farwaniya Hospital; 🇰🇼 Farwaniya, Kuwait

Al-Adan Hospital; 🇰🇼 Hadiya, Kuwait

Al-Amiri Hospital; 🇰🇼 Kuwait City, Kuwait

National Diabetes and Endocrine Center; 🇴🇲 Muscat, Oman

Samail Polyclinic; 🇴🇲 Samail, Oman

Hamad General Hospital; 🇶🇦 Doha, Qatar

PHCC; 🇶🇦 Doha, Qatar