Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000972527
Ethics application status
Approved
Date submitted
5/07/2024
Date registered
9/08/2024
Date last updated
9/08/2024
Date data sharing statement initially provided
9/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Prevention and treatment of type 1 diabetes using natural compound sulforaphane
Scientific title
Targeting ferroptosis in diabetes and diabetic complications by hydrogen (per)sulfide in males 18 - 65 years old
Secondary ID [1] 312453 0
This research is part of the project "PRIZMA" registered by Ministry of Education, Science and Technological Development Number 6677.
Universal Trial Number (UTN)
Trial acronym
DiaSulFer
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes type 1 334287 0
Condition category
Condition code
Metabolic and Endocrine 330942 330942 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The clinical study will be conducted as a randomized, double-blind, placebo-controlled trial. Sixty adult male participants (18-65 years old) will be recruited at the Clinic of Endocrinology, Diabetes and Metabolic Disease, University Clinical Center of Serbia, Belgrade. The study inclusion criteria will be as follows: confirmed diabetes type 1 (T1D) for less than 15 years, intensive insulin substitution or subcutaneous insulin infusion therapy, body mass index less than 35 kg/m² and informed consent signed. The participants from the intervention group will take orally 36 mg (83 µM) of activated sulforaphane precursor, glucoraphanin (sulforaphane glucosinolate) daily for three months. Intervention capsules contain 18 mg glucoraphanin from broccoli seeds and 2.8 µM myrosinase (activating enzyme). The placebo group will take capsules with microcrystalline cellulose (placebo). All participants will be asked to take 2 capsules after breakfast, Taking capsules will be monitored once per week through phone interviews. Participants will be asked to bring back non-used capsules, and study compliance will be assessed by capsules accountability,
Intervention code [1] 328959 0
Treatment: Other
Comparator / control treatment
Control group (placebo) will take capsules with microcrystalline cellulose. Capsules will be composed of hydroxypropylmethylcellulose (HPMC)
Control group
Placebo

Outcomes
Primary outcome [1] 338707 0
Changes in anthropometric (body weight, height and waist and hip circumference), haematological and basic biochemical/metabolic parameters (lipid status, glucose, insulin, C-peptid, glycosylated hemoglobin (HbA1C), alanine transaminase (ALT), aspartate aminotransferase (AST) - serum/plasma assay. All of these parameters will be assessed together as a composite primary outcome.
Timepoint [1] 338707 0
90 days after intervention commencement
Primary outcome [2] 338708 0
Changes on parameters related to iron accumulation (level of iron, ferritin, haptoglobin, total iron-binding capacity, transferrin saturation) will be assessed together as a composite primary outcome.
Timepoint [2] 338708 0
90 days after intervention commencement
Primary outcome [3] 338711 0
Changes in inflammation parameters (C-reactive protein, interleukin-6, tumor necrosis factor-alpha), pro-ferroptotic parameters such as lipid peroxidation end-products (malondialdehyde, thiobarbituric acid reactive substance from serum and redox (antioxidative) status (glutathione level, activity of copper-zinc-superoxide dismutase, catalase, glutathione peroxidase will be assessed together as a composite primary outcome.
Timepoint [3] 338711 0
90 days after intervention commencement
Secondary outcome [1] 437082 0
Changes in proportion of persulfidated proteins in red blood cells lysates in experimental and a matched placebo group as well inside groups (before and after intervention)
Timepoint [1] 437082 0
90 days after intervention commencement

Eligibility
Key inclusion criteria
The study inclusion criteria will be as follows: confirmed T1D for less or equal 15 years, intensive insulin substitution or subcutaneous insulin infusion therapy, body mass index (BMI) less than35 kg/m² and informed consent signed.
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will be: impaired thyroid function with inadequate therapy, severe diseases (cancer, cardiac, neurological)

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)
Allocation by numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Method used to create the random order for the allocation of subjects into different groups will be simple randomisation using a randomisation table created by computer software
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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
T-test, Pearsons/Spearman correlation analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/08/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 26407 0
Serbia and Montenegro
State/province [1] 26407 0
Serbia

Funding & Sponsors
Funding source category [1] 316869 0
Government body
Name [1] 316869 0
The Science Fund of the Republic of Serbia
Country [1] 316869 0
Serbia and Montenegro
Primary sponsor type
Government body
Name
The Science Fund of the Republic of Serbia
Address
Country
Serbia and Montenegro
Secondary sponsor category [1] 319110 0
None
Name [1] 319110 0
Address [1] 319110 0
Country [1] 319110 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315627 0
Ethics Committee Faculty of Medicine, University of Belgrade (License number No. 1322-IX/40).
Ethics committee address [1] 315627 0
Ethics committee country [1] 315627 0
Serbia and Montenegro
Date submitted for ethics approval [1] 315627 0
26/09/2022
Approval date [1] 315627 0
29/09/2022
Ethics approval number [1] 315627 0

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

Contacts
Principal investigator
Name 135310 0
Dr Vesna Otasevic
Address 135310 0
Bulevar despota Stefana 142, Belgrade, 11000, Serbia, Institute for Biological Research "Siniša Stankovic" (IBISS), National Institute of Republic of Serbia, University of Belgrade
Country 135310 0
Serbia and Montenegro
Phone 135310 0
+381638602852
Fax 135310 0
Email 135310 0
[email protected]
Contact person for public queries
Name 135311 0
Vesna Otasevic
Address 135311 0
Bulevar despota Stefana 142, Belgrade, 11000, Serbia, Institute for Biological Research "Siniša Stankovic" (IBISS), National Institute of Republic of Serbia, University of Belgrade
Country 135311 0
Serbia and Montenegro
Phone 135311 0
+381638602852
Fax 135311 0
Email 135311 0
[email protected]
Contact person for scientific queries
Name 135312 0
Vesna Otasevic
Address 135312 0
Bulevar despota Stefana 142, Belgrade, 11000, Serbia, Institute for Biological Research "Siniša Stankovic" (IBISS), National Institute of Republic of Serbia, University of Belgrade
Country 135312 0
Serbia and Montenegro
Phone 135312 0
+381638602852
Fax 135312 0
Email 135312 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?




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.