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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03889210




Registration number
NCT03889210
Ethics application status
Date submitted
18/03/2019
Date registered
26/03/2019

Titles & IDs
Public title
ß-hydroxybutyrate, Glucose Metabolism and Prediabetes
Scientific title
Cross-over, Placebo-controlled, Randomized Trial of ß-hydroxybutyrate in Prediabetes
Secondary ID [1] 0 0
18/NTB/161
Universal Trial Number (UTN)
Trial acronym
CETUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
PreDiabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Metabolic and Endocrine 0 0 0 0
Diabetes
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - HVMN Ketone
Other interventions - Placebo

Active comparator: HVMN ketone drink - HVMN ketone drink will be given in a total volume of 100 ml.

Placebo comparator: Placebo - Placebo will be given in a total volume of 100 ml.


Other interventions: HVMN Ketone
Water-based, flavoured sport beverage

Other interventions: Placebo
Water, stevia, malic acid, and thickening agent
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of change in plasma glucose concentration
Timepoint [1] 0 0
Baseline, 30, 60, 90, 120, and 150 minutes
Secondary outcome [1] 0 0
Rate of change in plasma insulin and C-peptide concentrations
Timepoint [1] 0 0
Baseline, 30, 60, 90, 120, and 150 minutes
Secondary outcome [2] 0 0
Rate of change in plasma concentration of gut and pancreatic hormones
Timepoint [2] 0 0
Baseline, 30, 60, 90, 120, and 150 minutes
Secondary outcome [3] 0 0
Rate of change in lipid profile and digestive enzymes
Timepoint [3] 0 0
Baseline, 30, 60, 90, 120, and 150 minutes
Secondary outcome [4] 0 0
Rate of change in plasma concentration of pro-inflammatory cytokines
Timepoint [4] 0 0
Baseline, 30, 60, 90, 120, and 150 minutes
Secondary outcome [5] 0 0
Rate of change in plasma concentration of markers of iron metabolism
Timepoint [5] 0 0
Baseline, 30, 60, 90, 120, and 150 minutes
Secondary outcome [6] 0 0
Correlation with body fat phenotypes
Timepoint [6] 0 0
150 minutes
Secondary outcome [7] 0 0
Correlation with body fat phenotypes
Timepoint [7] 0 0
150 minutes
Secondary outcome [8] 0 0
Correlation with body fat phenotypes
Timepoint [8] 0 0
150 minutes
Secondary outcome [9] 0 0
Correlation with physical activity
Timepoint [9] 0 0
150 minutes

Eligibility
Key inclusion criteria
* Individuals over 18 years
* Individuals diagnosed with prediabetes; defined based on the American Diabetes Association guidelines
* History of at least one episode of acute pancreatitis
* Written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Individuals who are on a ketogenic diet or consuming nutritional ketone supplements
* History of cancer or chronic pancreatitis
* History of bariatric or gastrointestinal surgery
* Pregnant or breastfeeding women
* Individuals involved in intensive endurance training or competitive athletics

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/08/2019
Sample size
Target
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03889210