Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000832774
Ethics application status
Approved
Date submitted
1/06/2022
Date registered
14/06/2022
Date last updated
11/10/2023
Date data sharing statement initially provided
14/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A physiological study of the effect of alpha-melanocyte stimulating hormone (alpha-MSH) on glucose tolerance in people with type 1 diabetes
Scientific title
A physiological study of the effect of alpha-MSH on glucose tolerance in people with type 1 diabetes
Secondary ID [1] 307209 0
Nil
Universal Trial Number (UTN)
U1111-1278-6707
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 326439 0
Condition category
Condition code
Metabolic and Endocrine 323720 323720 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
10ug/ml alpha-MSH in saline administered via intravenous infusion at 1500ng/kg/hr, commencing at time -30 minutes and continued until time 180 minutes. At time 0 minutes, participants will consume a drink containing 75g glucose within 5 minutes. The intravenous infusion and glucose challenge will be supervised by a research nurse. The wash out period between the intervention and comparator treatments will be at least 2 days and no longer than 6 weeks. Participants will be asked to administer half of the usual insulin dose they would normally take to cover the glucose load immediately prior to consuming the glucose drink (time 0 minutes), or if they use an insulin pump, asked to set the pump to a temporary basal rate immediately prior to the infusion (-30 minutes). The study doctor will consult with each participant to formulate a plan for insulin dosing before and during the oral glucose tolerance test.
Intervention code [1] 323654 0
Treatment: Drugs
Comparator / control treatment
Matched saline placebo intravenous infusion, commencing at time -30 minutes and continued until time 180 minutes. At time 0 minutes, participants will consume a drink containing 75g glucose. The intravenous infusion and glucose challenge will be supervised by a research nurse. Participants will take the same insulin dose across both treatment visits.
Control group
Placebo

Outcomes
Primary outcome [1] 331469 0
Two-hour area under the curve blood plasma glucose concentration following 75g oral glucose commencing at time 0 minutes and calculated using measures collected at 0, 15, 30, 60, 90 and 120 minutes.
Timepoint [1] 331469 0
0, 15, 30, 60, 90 and 120 minutes relative to consumption of the glucose drink.
Secondary outcome [1] 410008 0
Blood plasma glucose concentrations at -30 and 180 minutes.
Timepoint [1] 410008 0
-30 minutes and 180 minutes relative to consumption of the glucose drink.
Secondary outcome [2] 410011 0
Blood serum insulin concentrations at -30, 0, 15, 30, 60, 90, 120 and 180 minutes.
Timepoint [2] 410011 0
-30, 0, 15, 30, 60, 90, 120 and 180 minutes relative to consumption of the glucose drink.
Secondary outcome [3] 410012 0
Blood serum c-peptide concentrations at -30, 0, 15, 30, 60, 90, 120 and 180 minutes.
Timepoint [3] 410012 0
-30, 0, 15, 30, 60, 90, 120 and 180 minutes relative to consumption of the glucose drink.
Secondary outcome [4] 410013 0
Blood plasma glucagon concentrations at -30, 0, 15, 30, 60, 90, 120 and 180 minutes.
Timepoint [4] 410013 0
-30, 0, 15, 30, 60, 90, 120 and 180 minutes relative to consumption of the glucose drink.
Secondary outcome [5] 410014 0
Blood plasma alpha-MSH concentrations at -30, 0, 15, 30, 60, 90, 120 and 180 minutes.
Timepoint [5] 410014 0
-30, 0, 15, 30, 60, 90, 120 and 180 minutes relative to consumption of the glucose drink.
Secondary outcome [6] 410015 0
Adverse events
Timepoint [6] 410015 0
At -30, 0, 30, 60, 90, 120 and 180 minutes relative to consumption of the glucose drink, participants will be asked whether they are feeling any tiredness, nausea or flushing. Participants will additionally be observed throughout the 3.5 hour infusion to monitor for adverse events, as well as for 30 minutes before commencing the infusion and 30 minutes after stopping the infusion. Within 48 hours of completing a treatment visit, a research nurse will call participants to enquire about any adverse events.

Eligibility
Key inclusion criteria
Type 1 diabetes with a confirmed diagnosis of at least 3 years' duration and a plasma or serum c-peptide of less than 0.1 nM.

BMI equal or greater than 18 and less than 30kg/m2, with a stable body weight for at least three months prior to enrolment.

Be able to read and understand the written information about the study and provide written consent to participate in it.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant current or past medical or psychiatric history that, in the opinion of the investigators, would pose unacceptable risk

Unwillingness or inability to follow the procedures outlined in the protocol

History of sensitivity to any of the peptides, or components thereof, or a history of drug or other allergy that, in the opinion of the investigators, would pose unacceptable risk

Clinically significant abnormalities in screening electrocardiogram (ECG) or blood tests which, in the opinion of the study physician, would pose unacceptable risk

Current pregnancy or breast-feeding in female participants or, if sexually active and of childbearing potential, unwilling to use effective contraception for the duration of the study

The participant has received an investigational product within the preceding 90 days, 5 half-lives or twice the duration of its biological effect (whichever is longer)

Exposure to more than 3 new investigational medicinal products within 12 months prior to the screening

Poor venous access

Unable or unwilling to wear a continuous glucose monitoring sensor for the duration of the study

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)
Opaque envelopes numbered 1 through 26 with group name A or B will be provided to the clinical trial pharmacist, who will open them in sequence to assign treatment. The study pharmacist will determine the key to the group name and will conceal group assignment from the investigators and statistician until all participants have completed the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The treatment randomisation schedule will be generated by the study statistician. The schedule will be prepared prior to the commencement of the study, and opaque envelopes with treatment assignment will be opened in order of participants entering the study visit.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
The analysis will be performed based on per protocol and only those who complete both assessments will be included in the AUC analysis. Demographic and clinical factors of those included in the study and those who withdrew will be reported.

Between group differences will be assessed using Wilcoxon matched-pairs signed rank test for continuous data and Fisher’s exact test for categorical data. Mixed effect model will be used to assess AUC differences between control and intervention arms.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/07/2022
Actual
26/09/2022
Date of last participant enrolment
Anticipated
14/04/2023
Actual
13/07/2023
Date of last data collection
Anticipated
12/05/2023
Actual
4/08/2023
Sample size
Target
26
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22432 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 37632 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 311510 0
Charities/Societies/Foundations
Name [1] 311510 0
Juvenile Diabetes Research Foundation (JDRF) International
Country [1] 311510 0
United States of America
Funding source category [2] 311513 0
Government body
Name [2] 311513 0
Victorian Government - Victorian Medical Research Accelerator Fund
Country [2] 311513 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road
Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 312924 0
None
Name [1] 312924 0
Address [1] 312924 0
Country [1] 312924 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310971 0
Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 310971 0
Ethics committee country [1] 310971 0
Australia
Date submitted for ethics approval [1] 310971 0
28/03/2022
Approval date [1] 310971 0
05/05/2022
Ethics approval number [1] 310971 0
HREC/85336/MH-2022

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

Contacts
Principal investigator
Name 119542 0
Dr John Wentworth
Address 119542 0
The Royal Melbourne Hospital
300 Grattan Street
Parkville VIC 3050
Country 119542 0
Australia
Phone 119542 0
+61 3 9342 7365
Fax 119542 0
Email 119542 0
[email protected]
Contact person for public queries
Name 119543 0
Felicity Healy
Address 119543 0
The Royal Melbourne Hospital
Level 4 West
300 Grattan Street
Parkville VIC 3050
Country 119543 0
Australia
Phone 119543 0
+61 3 9342 7063
Fax 119543 0
+61 3 9342 7278
Email 119543 0
[email protected]
Contact person for scientific queries
Name 119544 0
John Wentworth
Address 119544 0
The Royal Melbourne Hospital
300 Grattan Street
Parkville VIC 3050
Country 119544 0
Australia
Phone 119544 0
+61 3 9342 7365
Fax 119544 0
Email 119544 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16190Informed consent form  [email protected] +61 3 9342 7063



Results publications and other study-related documents

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