Prevalence of Overweight and Obesity in Adult Patients Su... | NCT05713448

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

NCT05713448

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Recruiting

Last Update Posted

Jul 1, 2024Actual

Enrollment

100,000Estimated

Phase

Not provided

Conditions

Type 1 Diabetes
Obesity

Interventions

No intervention

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 24, 2021Actual

Primary Completion Date

Dec 29, 2099Estimated

Completion Date

Dec 29, 2099Estimated

First Submitted Date

Oct 12, 2022

First Submission Date that Met QC Criteria

Jan 26, 2023

First Posted Date

Feb 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2024

Last Update Posted Date

Jul 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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, ...

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

100 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Type 1 diabetes		Individuals with type 1 diabetes	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	Type 1 diabetes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of patients with type 1 diabetes and obesity	Prevalence of obesity in type 1 diabetes	Up to 100 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent
Type 1 Diabetes

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Individuals with type 1 diabetes

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bart Van der Schueren, MD, PhD	Contact	+3216346994		bart.vanderschueren@uzleuven.be

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Departement Endocrinology, University Hospitals Leuven	Recruiting	Leuven		3000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1
D009765	Obesity

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided