NCT05642533

Brief Summary

The purpose of this research study is to collect information on participants body weight, blood sugar levels, heart related diseases and lifestyle. The collected information will help estimate the prevalence of participants disease. This study will take about 6 months. However, participants involvement in the study will not extend beyond their routine visit and will thus require a maximum of 1 day. If participants choose to take part, they will be asked to give information about their health in routine clinical visit. Participants will be asked to complete a questionnaire about their lifestyle. Participants will complete this questionnaire during their normally scheduled visit with their doctor. Participants will continue their normal way of life and will not get any medication other than those prescribed to them by their doctor. Participants will have no direct benefit from participation in this study and there are no risks involved. Participants decide voluntarily whether they want to participate in this study or not. Participants' decision will not affect their medical care and they do not have to justify their decision. Participants are free to leave the study at any time and without giving reasons. This does not affect their current or future treatment. The data collected up to that point are still being evaluated. There is no additional cost to participants for being in this study.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,061

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 8, 2022

Completed
23 days until next milestone

Study Start

First participant enrolled

December 31, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2023

Completed
Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

9 months

First QC Date

November 30, 2022

Last Update Submit

December 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of people with obesity without a history of Type 2 diabetes (T2D) who have Cardiovascular disease (CVD)s (pre-existing or newlydiagnosed)

    Percentage (and 95% confidence interval \[CI\])

    At time of patient enrollment/cross-sectional routine visit (DAY 1)

Study Arms (2)

Without a history of Type 2 diabetes

Adults with obesity

Other: No treatment given

With a history of Type 2 diabetes

Adults with obesity

Other: No treatment given

Interventions

No treatment given

With a history of Type 2 diabetesWithout a history of Type 2 diabetes

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will include adults with obesity, either without a history of T2D (Cohort 1) or with a history of T2D (Cohort 2).

You may qualify if:

  • Signed consent obtained before any study related activities (study related activities are any procedure-related to recording of data according to the protocol).
  • Diagnosed with obesity (BMI higher than or equal to 30 for all ethnic groups except Asian; BMI higher than or equal to 27.5 for patients of Asian ethnicity).
  • Diagnosed with T2D for patients in Cohort 2.
  • Male or female, aged between 18 and 75 years at the time of signing informed consent

You may not qualify if:

  • Participation in an interventional clinical trial during the study period.
  • Diagnosed with T2D for patients in Cohort 1.
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Clinical Transparency (dept. 2834)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 30, 2022

First Posted

December 8, 2022

Study Start

December 31, 2022

Primary Completion

September 14, 2023

Study Completion

September 14, 2023

Last Updated

December 30, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

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

More information