Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000367943
Ethics application status
Approved
Date submitted
20/02/2020
Date registered
17/03/2020
Date last updated
17/03/2020
Date data sharing statement initially provided
17/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Gastric emptying and post-meal blood sugar and gut hormones responses in healthy Indigenous Australians
Scientific title
Gastric emptying, incretin hormones and glycaemia in non-diabetic Indigenous Australians – implications for the pathogenesis of type 2 diabetes
Secondary ID [1] 300614 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 316377 0
Condition category
Condition code
Metabolic and Endocrine 314635 314635 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single visit study.
All participants will consume an oral drink containing 75g glucose within 5 minutes.
Gastric emptying will be measured by scintigraphy (nuclear medicine technique). Blood glucose, insulin and gut hormones will be estimated from venous blood sampling.
Intervention code [1] 316927 0
Diagnosis / Prognosis
Comparator / control treatment
No comparator or control treatment group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322963 0
Rate of gastric emptying as assessed by scintigraphy to oral glucose in non-diabetic Aboriginals compared with non-diabetic Caucasians
Timepoint [1] 322963 0
Gastric emptying data will be recorded in 30second frames for the first 30 minutes (T=0 min to T=30 min), followed by 3 minute frames for the next 210 minutes (T=30 min to T=240 min).
Secondary outcome [1] 380386 0
Postprandial glucose as assessed by blood glucose to oral glucose in non-diabetic Aboriginals compared with non-diabetic Caucasians
Timepoint [1] 380386 0
Venous blood will be sampled at regular intervals beginning with basal blood specimens at T = –5 min and then at 15, 30, 45, 60, 75, 90, 105, 120, 180 and 240 min for measurement of glucose

Eligibility
Key inclusion criteria
A) For all participants:
• Male and female aged 18 – 70 years
• Body mass index (BMI) 20 - 30 kg/m2
• Normotensive (BP < 140/90)
• Haemoglobin in the normal range.
• Ability to understand the Participant Information and Consent Form and provide written consent.

B) For inclusion in the Aboriginal cohort, the following applies:
For the purposes of the study, a participant will be considered an ‘Aboriginal’ if he or she fulfills the three-part definition of an Aboriginal person proposed by the Commonwealth Department of Aboriginal Affairs i.e. “An Aboriginal or Torres Strait Islander is a person of Aboriginal or Torres Strait Islander descent who identifies as an Aboriginal or Torres Strait Islander and is accepted as such by the community in which he [or she] lives”.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Glycated haemoglobin greater than 6.5%
• Past history of gastrointestinal surgery (except appendicectomy)
• Medication(s) which may affect gastrointestinal motor function, body weight or appetite
• Other significant illness, including epilepsy, cardiovascular or respiratory disease
• History of gastrointestinal disease, including pancreatitis, chronic abdominal symptoms
• Evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes per day
• Impaired renal function (eGFR of less than 60 mL/min/1.73 m2).
• Impaired liver function (liver enzymes greater than twice the upper limit of normal).
• Donation of blood within the previous 3 months
• Radiation exposure within the past 12 months for research studies
• Pregnant or breast-feeding women

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/04/2017
Date of last participant enrolment
Anticipated
26/02/2021
Actual
Date of last data collection
Anticipated
30/04/2021
Actual
Sample size
Target
12
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 305033 0
Hospital
Name [1] 305033 0
Royal Adelaide Hospital Clinical Project Grant
Country [1] 305033 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Royal Adelaide Hospital
Port Rd, Adelaide SA 5000, Australia
Country
Australia
Secondary sponsor category [1] 305395 0
None
Name [1] 305395 0
None
Address [1] 305395 0
Not applicable
Country [1] 305395 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305429 0
CALHN Health Research Ethics Committee
Ethics committee address [1] 305429 0
Ethics committee country [1] 305429 0
Australia
Date submitted for ethics approval [1] 305429 0
23/04/2015
Approval date [1] 305429 0
19/10/2015
Ethics approval number [1] 305429 0

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

Contacts
Principal investigator
Name 100350 0
Dr Chinmay Marathe
Address 100350 0
Faculty of Health and Medical Sciences,
University of Adelaide
Level 5, AHMS Building, North Terrace, Adelaide SA 5000
Country 100350 0
Australia
Phone 100350 0
+61 431266075
Fax 100350 0
Email 100350 0
[email protected]
Contact person for public queries
Name 100351 0
Chinmay Marathe
Address 100351 0
Faculty of Health and Medical Sciences,
University of Adelaide
Level 5, AHMS Building, North Terrace, Adelaide SA 5000
Country 100351 0
Australia
Phone 100351 0
+61 431266075
Fax 100351 0
Email 100351 0
[email protected]
Contact person for scientific queries
Name 100352 0
Chinmay Marathe
Address 100352 0
Faculty of Health and Medical Sciences,
University of Adelaide
Level 5, AHMS Building, North Terrace, Adelaide SA 5000
Country 100352 0
Australia
Phone 100352 0
+61 431266075
Fax 100352 0
Email 100352 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will generally not be shared unless it is de-identified or adviced to do by ethics committee


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7005Study protocol  [email protected]
7006Clinical study report  [email protected]
7007Ethical approval  [email protected]



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.