POOT1: Prevalence of Overweight and Obesity in Adult Patients Suffering From Type 1 Diabetes

• Sponsor: Universitaire Ziekenhuizen KU Leuven (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05713448
• Collaborator: (none)
• Enrollment: 100,000
• Location: 1
• Anticipated Duration (Months): 946.1
• Patients Per Site Per Month: 105.7

Study Details

Study Description

Brief Summary

A registry of individuals with type 1 diabetes that visited the Department of Endocrinology of the University Hospitals of Leuven is established. The objective of this registry is to phenotype patients with type 1 diabetes and obesity and their response to treatment with regard to their outcomes

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes; Obesity	Other: No intervention

Detailed Description

A registry/database is constructed with data of the individuals with type 1 diabetes that visited the Department of Endocrinology of the University Hospitals of Leuven. Data will be obtained from all visits in terms of sociodemographics, disease origin and disease impact including but not limited to glycemic control, medical history, comorbidities, complications, clinical parameters, anthropometric parameters, biochemical blood values, medical therapy, lifestyle, ...

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 100000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prevalence of Overweight and Obesity in Adult Patients Suffering From Type 1 Diabetes and Its Effect on Treatment and Associated Co-morbidities
• Actual Study Start Date: Feb 24, 2021
• Anticipated Primary Completion Date: Dec 29, 2099
• Anticipated Study Completion Date: Dec 29, 2099

Arms and Interventions

Arm	Intervention/Treatment
Type 1 diabetes Individuals with type 1 diabetes	Other: No intervention; No intervention

Outcome Measures

Primary Outcome Measures

1. Routine treatment data [Up to 100 years]

   The objective is to collect routine treatment data (sociodemographics, treatment and treatment outcome, disease impact, biochemistry, questionnaires, ...) using the electronic medical record

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Signed informed consent

• Type 1 Diabetes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Departement Endocrinology, University Hospitals Leuven	Leuven		Belgium	3000

Sponsors and Collaborators

• Universitaire Ziekenhuizen KU Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universitaire Ziekenhuizen KU Leuven
• ClinicalTrials.gov Identifier: NCT05713448
• Other Study ID Numbers: S64223
• First Posted: Feb 6, 2023
• Last Update Posted: Feb 6, 2023
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 1; Overweight

Study Results

No Results Posted as of Feb 6, 2023