Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000956303
Ethics application status
Approved
Date submitted
29/06/2017
Date registered
4/07/2017
Date last updated
27/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The metabolic and body composition effects of a CREBRF gene variant in healthy adults
Scientific title
The metabolic and body composition effects of a CREBRF gene variant in healthy adults
Secondary ID [1] 292289 0
Nil
Universal Trial Number (UTN)
U1111-1198-3754
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic diseases 303809 0
Obesity 303856 0
Condition category
Condition code
Diet and Nutrition 303176 303176 0 0
Obesity
Metabolic and Endocrine 303250 303250 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mixed meal tolerance test: A high carbohydrate (60g) and fat (20g) meal. Test food will be delivered in both a liquid drink and typical breakfast food. Blood samples (10ml) will be taken from a cannula pre meal and every 15-30 minutes for 2 hours, For the whole day the total volume of blood taken will be 250 ml, this is less than 1 cup and half the volume of a blood donation. This will occur at the clinic rooms at The University of Auckland and administered by the PI.

We will also collect respiratory samples and body composition measures prior to this meal.
Intervention code [1] 298461 0
Early detection / Screening
Comparator / control treatment
We are comparing individuals who have the CREBRF variant to those that do not.
Control group
Active

Outcomes
Primary outcome [1] 302556 0
Objective: To asses the body compostion in individuals with the CREBRF variant in a New Zealand population.

Primary outcome: Body composition measured using a dual energy X-ray absorptiometry test.
Timepoint [1] 302556 0
Baseline (primary endpoint).
Secondary outcome [1] 336457 0
Resting metabolic rate will be measured using respiratory data collected using a metabolic cart.
Timepoint [1] 336457 0
Baseline
Secondary outcome [2] 336557 0
Blood samples will be assessed for blood glucose response to mixed meal test
Timepoint [2] 336557 0
Baseline and every 30 minutes after test food consumption for 2 hours.
Secondary outcome [3] 336558 0
Blood samples will be assessed for triglyceride response to mixed meal test
Timepoint [3] 336558 0
Baseline and every 30 minutes after test food consumption for 2 hours.

Eligibility
Key inclusion criteria
Aged 18-50 years, male or female.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Have diabetes
Have any long-term serious medical conditions

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
ANOVA or non-parametric tests where appropriate and followed up with post-hoc tests will be used to determine differences in end points. Significance will be accepted at P<0.05.

Endpoints
Primary endpoint
• Body composition

Secondary endpoints
• Metabolic response to a mixed meal
• Resting energy expenditure

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/07/2017
Actual
25/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
125
Final
Recruitment outside Australia
Country [1] 9027 0
New Zealand
State/province [1] 9027 0
Auckland, Northland, Gisbourne

Funding & Sponsors
Funding source category [1] 296832 0
Charities/Societies/Foundations
Name [1] 296832 0
Auckland Medical Research Foundation
Country [1] 296832 0
New Zealand
Funding source category [2] 296860 0
Other Collaborative groups
Name [2] 296860 0
Maurice Wilkins Centre
Country [2] 296860 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
85 Park Road
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 295824 0
None
Name [1] 295824 0
Address [1] 295824 0
Country [1] 295824 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298064 0
Health and Disability Ethics Committee
Ethics committee address [1] 298064 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 298064 0
New Zealand
Date submitted for ethics approval [1] 298064 0
Approval date [1] 298064 0
12/06/2017
Ethics approval number [1] 298064 0
17/STH/79

Summary
Brief summary
Fat rather than body weight is the greatest risk factor for type 2 diabetes. Body mass index (BMI: calculated by height divided by weight squared) is often used as a measure of body fat. However, in some people it does not accurately reflect the amount of fat. This is interesting because it has recently been found that people with a small change (variant) in a gene called CREBRF have a higher BMI, but a LOWER risk of developing type 2 diabetes. In this study we are investigating whether people with a CREBRF gene variant have different lean (muscle) or fat mass, and we are trying to understand how this gene variant lowers the risk of developing type 2 diabetes
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75874 0
Dr Troy Merry
Address 75874 0
University of Auckland
504-201, Faulty of Medicine and Health Science
85 Park Road
Grafton
Auckland 1023
Country 75874 0
New Zealand
Phone 75874 0
+64 9 923 9008
Fax 75874 0
Email 75874 0
[email protected]
Contact person for public queries
Name 75875 0
Dr Troy Merry
Address 75875 0
University of Auckland
504-201, Faulty of Medicine and Health Science
85 Park Road
Grafton
Auckland 1023
Country 75875 0
New Zealand
Phone 75875 0
+64 9 923 9008
Fax 75875 0
Email 75875 0
[email protected]
Contact person for scientific queries
Name 75876 0
Dr Troy Merry
Address 75876 0
University of Auckland
504-201, Faulty of Medicine and Health Science
85 Park Road
Grafton
Auckland 1023
Country 75876 0
New Zealand
Phone 75876 0
+64 9 923 9008
Fax 75876 0
Email 75876 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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