A Study to Understand the Distribution of Obesity Classes and Obesity Related Diseases in People With Obesity Across Countries in Czech Republic, Hungary and Poland (ExplorEUEast)

August 27, 2024 updated by: Novo Nordisk A/S

A Multicentre, Observational Study to Understand the Distribution of Obesity Classes and Obesity Related Comorbidities (ORCs) in People With Obesity Within a Real World Population in Czech Republic, Hungary and Poland

The study is intended to understand the distribution of different obesity classes and obesity related diseases (diseases that present along with obesity) in patients with body mass index (BMI) ≥ 30 kg/m^2.

Participants will be asked to give information about their health. They will continue their normal way of life and will not get any medication or additional medical test other than those prescribed to you by their doctor. Participation in the study will last for about 1 day.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1241

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Chocen, Czechia, 56501
        • Poliklinika Chocen a.s.
  • Hungary
      • Biatorbágy, Hungary, 2071
        • Dr. Dozsa Katalin Maria EV
      • Budapest, Hungary, 1136
        • Dr. Torzsa Peter Bt.
      • Szentendre, Hungary, 2000
        • DRC Szentendre
      • Szentlorinc, Hungary, 7940
        • Pecsi Tudomanyegyetem
      • Szigethalom, Hungary, 2315
        • Co-Medi-Catus Kft.
  • Poland
      • Białystok, Poland, 00-002
        • Akademicka Praktyka Medycyny Rodzinnej Bielska Chlabicz Czarnowski Oltarzewska Sawicka Powierza
      • Bydgoszcz, Poland, 85-796
        • Centrum medyczne Pratia Bydgoszcz
      • Gizycko, Poland, 00-002
        • Niepuliczny Zaklad Opieki Zdrowotnej
      • Koluszki, Poland, 00-002
        • Niepubliczny Zaklad Opieki Zdrowotnej NZOZ ESKULAP s c
      • Ksiaz Wielkopolski, Poland, 00-002
        • Bellus Przychodnia Lekarza Rodzinnego
      • Lodz, Poland, 00-002
        • Aloes sp. z.o. o
      • Lodz, Poland, 00-002
        • SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia
      • Lublin, Poland, 00-002
        • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
      • Nowy Targ, Poland, 00-002
        • ALLMEDICA sp. z o. o.
      • Olsztyn, Poland, 00-002
        • FutureMeds Olsztyn
      • Skierniewice, Poland, 00-002
        • Clinmedica Research spzo.o
      • Swidnica, Poland, 00-002
        • DC-MED
      • Warszawa, Poland, 00-002
        • ETG Warszawa
      • Wroclaw, Poland, 000
        • Przychodnia VISTAMED

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with obesity coming into the clinic as part of routine visit to their treating physician/general practitioner

Description

Inclusion Criteria:

  1. Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
  2. Male or female, age greater than or equal to 18 years at the time of inclusion/enrolment in the study.
  3. BMI greater than or equal to 30 Kg/m^2 as measured at the inclusion in the study

Exclusion Criteria:

  1. Previous participation in this study. Participation is defined as having given informed consent in this study.
  2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation as judged by physician.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
People with obesity
Patients with obesity coming into the clinic as part of routine visit to their treating physician/general practitioner
Other: No treatment given
No treatment given

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with at least one obesity related comorbidity of interest for obesity classes I, II and III pooled across all countries
Time Frame: At the time of enrolment (Day 1)
% patients with obesity
At the time of enrolment (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2023

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

March 21, 2023

First Submitted That Met QC Criteria

March 21, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAS-7530
  • U1111-1277-8275 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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