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
Royal Adelaide Hospital
Royal Adelaide Hospital
Clinical Trial Centre
Wayfinder 3D460.02
Level 3
Port Road
ADELAIDE SA 5000
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
The incidence of type 2 diabetes in the Aboriginal community is particularly high, about three times greater and up to five times in the age group of 35-44 years compared with Caucasians. The consequences of this are grave and studies have suggested there is a 17-year gap in life expectancy between Indigenous and Caucasians in Australia for which diabetes is a major contributor. An understanding of the inherent differences between Aboriginal and Caucasian groups in the pathogenesis of type 2 diabetes is of major clinical relevance if we are to take steps to bridge this gap and target lifestyle and pharmacological managements effectively.


This study is designed to provide new information about the way the gastrointestinal tract (stomach and intestines) contributes to development of type 2 diabetes. It is well recognised that the presence of nutrients in the small intestine triggers the release of certain hormones from the gut. We are interested in studying two gut hormones in particular, GLP-1 and GIP (also referred to as the ‘incretin’ hormones). The incretin hormones have been found to play a critical role in maintaining blood sugar levels. Similarly, the rate at which food is emptied from the stomach to the small intestine (referred to as ‘gastric emptying’) is also crucial.

The aim of the study is to determine if, following a standard meal, the gastric emptying or the response by the incretin hormones (GLP-1, GIP) is altered in the indigenous community compared with Caucasians. We will recruit both aboriginal and non-aboriginal participants in this study.
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
Dr 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
Dr 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.