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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07001553




Registration number
NCT07001553
Ethics application status
Date submitted
22/05/2025
Date registered
3/06/2025
Date last updated
3/06/2025

Titles & IDs
Public title
Understanding Acute Dietary Changes After GLP-1 Agonist Treatment: The GLaD Feasibility Study
Scientific title
Understanding the Dietary Adjustments Following GLP-1 Agonist Treatment: The GLaD Feasibility Study
Secondary ID [1] 0 0
2025-4090H
Universal Trial Number (UTN)
Trial acronym
GLaD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Type 2 Diabetes Mellitus (T2DM) 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Weight management - Prescribed GLP-1 agonist therapy primarily for weight management

Type 2 diabetes - Prescribed GLP-1 agonist therapy primarily for glycemic management
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility of recruitment
Timepoint [1] 0 0
4 months
Secondary outcome [1] 0 0
Energy intake
Timepoint [1] 0 0
baseline, 2 weeks, 1 month, 3 months
Secondary outcome [2] 0 0
Medication symptomology
Timepoint [2] 0 0
baseline, 1 month, 3 months
Secondary outcome [3] 0 0
Medication use
Timepoint [3] 0 0
baseline, 1 month, 3 months

Eligibility
Key inclusion criteria
* Aged 18+ years old
* Intending to commence a prescription for a GLP-1 agonist (may be dual agonist, i.e. Ozempic, Trulicity, Monjaro, or Saxenda) medication, with no use in the previous 6 months
* The primary reason for commencing the medication will be for diabetes or weight management
* Willing to participate in dietary recall and questionnaires
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Aged under 18 years,
* used a GLP-1 agonist medication in the previous 6 months,
* unwilling or unable to provide dietary recalls
* non-English speaking.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
31/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
22/12/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Australian Catholic University - Fitzroy
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy

Funding & Sponsors
Primary sponsor type
Other
Name
Australian Catholic University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
St Vincent's Hospital Melbourne
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The University of Queensland
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Evelyn B Parr, PhD
Address 0 0
Australian Catholic University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Evelyn B Parr, PhD
Address 0 0
Country 0 0
Phone 0 0
+61392308278
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07001553