Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000619842
Ethics application status
Approved
Date submitted
6/06/2012
Date registered
8/06/2012
Date last updated
10/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Do blood glucose levels after meals relate to gut hormones, stomach emptying, and nervous system function in young people with type 1 diabetes?
Scientific title
Incretin release, gastric emptying and post prandial glycaemia in type 1 diabetes and the relationship with autonomic dysfunction.
Secondary ID [1] 280635 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 286646 0
Condition category
Condition code
Metabolic and Endocrine 286934 286934 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Subjects with type 1 diabetes (T1D) will have 1 study day, on which they will consume a standard pancake at approximately 8.30am, after fasting from both solids and liquids from 10pm the previous evening. There should be no risk to subjects fasting from 10pm. If they develop hypoglycaemia they should manage it with the standard treatment (ie. Glucose tablets). Morning insulin will not be given until they are at the hospital and have commenced the study. All T1D subjects will have duration of T1D and HbA1c at the time of the study recorded.

Insulin administration
T1D subjects will administer their ultrashort insulin analog (novorapid) immediately before the ingestion of the meal at time -15minutes, via subcutaneous injection or an insulin pump. The dose of ultrashort insulin analog for the standard pancake will be calculated for each subject according to their prescribed carbohydrate ratio (units of insulin/grams of carbohydrate). This is usually 2-3 units per 15g of carbohydrate.

Pancake
Each subject will consume the pancake within 5min and t = 0 is defined as the time of meal completion. The standard pancake (70g of Green’s (Trademark) Pancake and Pikelet Mix mixed with 100mL water and cooked with 10g butter; total of 13.5 g fat, 44.2g of carbohydrate, 252 calories) will be given to the T1D subjects.
After consuming the pancake T1D subjects will undergo a gastric emptying breath test and measurement of incretin hormones over 4 hours.
An ECG recording over 20 minutes using AD Instruments PowerLab system (Amsterdam, Holland) will measure (i) mean resting heart rate (HR) and HR variability parameters (ii) standard deviation of adjacent QRS complexes (iii) mean square root of successive QRS intervals, an estimate of overall HR variability (iv) lower:higher frequency ratio: an estimate of sympathetic/parasympathetic balance.
Intervention code [1] 285032 0
Not applicable
Comparator / control treatment
The department of gastroenterology has been collecting gastric empyting data on healthy controls (n=12) over the last 11 years. These controls can be used for the T1D subjects who are having the standard pancake. HRV control data in the 10-18 year old group (n= 118) has been collected at CHW, NSW over the last 5 years (co-investigator KD).
Control group
Historical

Outcomes
Primary outcome [1] 287284 0
Quantify gastric emptying and the post prandial secretion of incretins in subjects with T1D

Tools:
Gastric Empyting:
13C labelled Na-octanoate (100mg) will be added to each pancake. Samples will be analysed for 13CO2 using an isotope ratio mass spectrometer. 13CO2 excretion rate will be used to calculate gastric emptying using a non-linear regression model as co -investigators have described.

Blood samples: Incretin hormones/insulin/glucagon/glucose.
Blood glucose concentration will be measured immediately using a glucometer (Medisense Companion 2), and the remainder of the sample will be placed in EDTA tubes containing aprotinin on ice. Plasma will be separated and samples stored at -70 degrees C for subsequent analysis of plasma insulin, glucagon, GLP-1, and GIP using established assays at Royal Adelaide Hospital.
Timepoint [1] 287284 0
times = -15, -5, 15, 30, 45, 60, 90, 120, 150, 180, 240 min
Secondary outcome [1] 297821 0
Determine heart rate variability (HRV) in subjects with T1D and its relationship with gastric emptying.

Tools:
Gastric Empyting:
13C labelled Na-octanoate (100mg) will be added to each pancake. Samples will be analysed for 13CO2 using an isotope ratio mass spectrometer. 13CO2 excretion rate will be used to calculate gastric emptying using a non-linear regression model as co -investigators have described.

ECG to measure HRV:
An ECG recording over 20 minutes using AD Instruments PowerLab system ( Amsterdam, Holland) will measure (i) mean resting heart rate (HR) and HR variability parameters (ii) standard deviation of adjacent QRS complexes (iii) mean square root of successive QRS intervals, an estimate of overall HR variability (iv) lower:higher frequency ratio : an estimate of sympathetic/parasympathetic balance.
Timepoint [1] 297821 0
Gastric Emptying times = -15, -5, 15, 30, 45, 60, 90, 120, 150, 180, 240 min

ECG occurs at 180mins

Eligibility
Key inclusion criteria
Duration of T1D greater than 1 year
Minimum age
10 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous gastrointestinal surgery (apart from uncomplicated appendicectomy), requirement for medications that could affect gastrointestinal motility (eg erythromycin, SSRIs), pregnancy or lactation.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/04/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285401 0
Charities/Societies/Foundations
Name [1] 285401 0
McLeod Trust
Country [1] 285401 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Adelaide Graduation Centre
The University of Adelaide
Level 6
115 Grenfell Street
South Australia
Adelaide 5000
Country
Australia
Secondary sponsor category [1] 284253 0
Hospital
Name [1] 284253 0
Womens and Children's Hospital
Address [1] 284253 0
72 King William Road
North Adelaide 5006
SA
Country [1] 284253 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287413 0
Womens and Children's Hospital Research Ethics Committee
Ethics committee address [1] 287413 0
Ethics committee country [1] 287413 0
Australia
Date submitted for ethics approval [1] 287413 0
Approval date [1] 287413 0
17/06/2012
Ethics approval number [1] 287413 0
2450

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

Contacts
Principal investigator
Name 34281 0
Dr Shiree Perano
Address 34281 0
72 King William Road
North Adelaide 5006
SA
Country 34281 0
Australia
Phone 34281 0
+61 8 81617000
Fax 34281 0
Email 34281 0
[email protected]
Contact person for public queries
Name 17528 0
Dr Shiree Perano
Address 17528 0
72 King William Road
North Adelaide 5006
SA
Country 17528 0
Australia
Phone 17528 0
+61 8 8161 7000
Fax 17528 0
Email 17528 0
[email protected]
Contact person for scientific queries
Name 8456 0
Dr Shiree Perano
Address 8456 0
72 King William Road
North Adelaide 5006
SA
Country 8456 0
Australia
Phone 8456 0
+61 8 8161 7000
Fax 8456 0
Email 8456 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
SourceTitleYear of PublicationDOI
Dimensions AIPancreatic Enzyme Supplementation Improves the Incretin Hormone Response and Attenuates Postprandial Glycemia in Adolescents With Cystic Fibrosis: A Randomized Crossover Trial2014https://doi.org/10.1210/jc.2013-4417
N.B. These documents automatically identified may not have been verified by the study sponsor.