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Trial registered on ANZCTR


Registration number
ACTRN12617001605381
Ethics application status
Approved
Date submitted
18/10/2017
Date registered
7/12/2017
Date last updated
5/11/2019
Date data sharing statement initially provided
21/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Can taking a plant extract improve blood glucose in adult men with pre-diabetes? First in human study
Scientific title
A first in human (FIH) clinical study to assess the effect of different doses of Dahlia spp. extract on glucose metabolism.
Secondary ID [1] 293154 0
Nil
Universal Trial Number (UTN)
UTN: U111112016917
Trial acronym
Nil
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Pre-Diabetes 305130 0
Diabetes 305131 0
Condition category
Condition code
Metabolic and Endocrine 304453 304453 0 0
Diabetes
Alternative and Complementary Medicine 304519 304519 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An extract of Dahlia spp. will be given at 3 different dosages on one occasion per dose, and an oral glucose tolerance test performed with each dosage. The doses will be 0.5, 1 and 2 mg/m2 given as capsules. All participants will receive all three doses with a one week washout period. The doses will be administered by a research nurse.
Intervention code [1] 299404 0
Treatment: Other
Comparator / control treatment
Each patient will act as their own control, as this is a first in human trial, with an OGTT first with no intervention administered.
Control group
Dose comparison

Outcomes
Primary outcome [1] 303695 0
Area under the curve glucose
Timepoint [1] 303695 0
Baseline, visits 1, 2 and 3. Blood samples will be collected at 30 minute intervals during the oral glucose tolerance test for 3 hours.
Primary outcome [2] 303696 0
Area under the curve insulin
Timepoint [2] 303696 0
Baseline, visits 1, 2 and 3. Blood samples will be collected at 30 minute intervals during the oral glucose tolerance test for 3 hours.
Secondary outcome [1] 339881 0
Safety measures - liver function, full blood count and kidney function as a composite outcome
Timepoint [1] 339881 0
Blood tests will be done the day before and day after the intervention to check liver function and full blood count and kidney function.
Secondary outcome [2] 340093 0
C-peptide
Timepoint [2] 340093 0
Baseline, Visits 1, 2 and 3
Secondary outcome [3] 340094 0
Blood pressure, heart rate, saturations, respiratory rate, temperature as a composite outcome reported as acute adverse events.
Timepoint [3] 340094 0
Observations done every 30 mins for 5 hours following administration of dose 1, 2 and 3 but not at baseline.

Eligibility
Key inclusion criteria
Males aged 18-65 years with pre-diabetes (HbA1c 41-49 mmol/mol)
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Any prior history of diabetes or taking glucose lowering medication
Previous bariatric surgery
Liver disease or AST/ ALT >3x ULN, Renal disease or eGFR <60.
Known cardiac disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Three doses are being tested, the order of dose administration will be randomised. The number of capsules will be consistent each time, with the rest of the dose being made up with dummy capsules.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The generation of dose randomisation will be computer generated.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The main outcomes are area under the curve (AUC) for glucose and insulin during the OGTT, using the trapezoidal method, and insulin sensitivity using the Matsuda index. The pre-specified contrasts are between baseline and dose 1, baseline and dose 2, baseline and dose 3 as well as dose 1 and dose 2, dose 2 and dose 3 and dose 1 and dose3. Other outcomes are change in glucose, insulin and insulin sensitivity measured by the homeostasis model assessment (HOMA) between T0 and 60 mins following each dose.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/12/2017
Actual
27/07/2018
Date of last participant enrolment
Anticipated
12/03/2019
Actual
4/03/2019
Date of last data collection
Anticipated
1/06/2019
Actual
26/03/2019
Sample size
Target
20
Accrual to date
Final
16
Recruitment outside Australia
Country [1] 9295 0
New Zealand
State/province [1] 9295 0
Wellington

Funding & Sponsors
Funding source category [1] 297781 0
University
Name [1] 297781 0
University of Otago
Country [1] 297781 0
New Zealand
Funding source category [2] 297782 0
Charities/Societies/Foundations
Name [2] 297782 0
New Zealand Society for the Study of Diabetes
Country [2] 297782 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Department of Physiology
Centre for Neuroendocrinology,
University of Otago
PO Box 56
DUNEDIN 9054
Country
New Zealand
Secondary sponsor category [1] 296817 0
Other
Name [1] 296817 0
Centre for Endocrine, Diabetes and Obesity Research
Address [1] 296817 0
Capital and Coast DHB
Wellington Hospital
Private Bag 7902
Wellington
Country [1] 296817 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298840 0
NZ Health and Disability Ethics Committee
Ethics committee address [1] 298840 0
Ethics committee country [1] 298840 0
New Zealand
Date submitted for ethics approval [1] 298840 0
07/09/2017
Approval date [1] 298840 0
12/10/2017
Ethics approval number [1] 298840 0
17/CEN/194

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

Contacts
Principal investigator
Name 78406 0
Dr Jeremy Krebs
Address 78406 0
Wellington Hospital Riddiford St Wellington 6021
Country 78406 0
New Zealand
Phone 78406 0
+64 4 8062458
Fax 78406 0
Email 78406 0
[email protected]
Contact person for public queries
Name 78407 0
Amber Parry Strong
Address 78407 0
Wellington Hospital Riddiford St Wellington 6021
Country 78407 0
New Zealand
Phone 78407 0
+64 4 8062458
Fax 78407 0
Email 78407 0
[email protected]
Contact person for scientific queries
Name 78408 0
Charles Barter
Address 78408 0
Wellington Hospital Riddiford St Wellington 6021
Country 78408 0
New Zealand
Phone 78408 0
+64 4 8062458
Fax 78408 0
Email 78408 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
This data is commercially sensitive and so is unable to be shared at this time.


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
No additional documents have been identified.