NCT06288399

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,316

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

October 15, 2025

Status Verified

October 1, 2025

Enrollment Period

9 months

First QC Date

February 23, 2024

Last Update Submit

October 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

Obesity Group

Adults with diagnosis of obesity and obesity-related comorbidities

Other: No treatment given

Interventions

No treatment given

Obesity Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with diagnosis of obesity and obesity-related comorbidities

You may qualify if:

  • Local national (male or female) of Arab ethnicity, age above or equal to 18 years at index date
  • Primary or secondary diagnosis of obesity (BMI above or equal to 30 kg/m2) at index date
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Farwaniya Hospital

Farwaniya, 85000, Kuwait

Location

Al-Adan Hospital

Hadiya, 52700, Kuwait

Location

Al-Amiri Hospital

Kuwait City, 13001, Kuwait

Location

National Diabetes and Endocrine Center

Muscat, 113, Oman

Location

Samail Polyclinic

Samail, 620, Oman

Location

Hamad General Hospital

Doha, 122104, Qatar

Location

PHCC

Doha, 122104, Qatar

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2024

First Posted

March 1, 2024

Study Start

December 21, 2023

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

October 15, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

More information

Locations