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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03889210
Ethics application status
Date submitted
18/03/2019
Date registered
26/03/2019
Date last updated
6/11/2019

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 - Changes in plasma glucose concentration before and after administration of the intervention/placebo
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 - Changes in plasma insulin and C-peptide concentrations before and after administration of the intervention/placebo
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 - Changes in plasma concentrations of ghrelin, incretins, cholecystokinin, gastrin-releasing peptide, peptide YY, oxyntomodulin, motilin, glucagon, amylin, pancreatic polypeptide, and vasoactive intestinal peptide before and after administration of the intervention/placebo
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 - Changes in plasma concentration of triglycerides, glycerol, cholesterol, lipases before and after administration of the intervention/placebo
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 - Changes in plasma concentration of interleukin-1ß, interleukin-6, leptin, tumor necrosis factor a, and monocyte chemoattractant protein-1 and other cytokines before and after administration of the intervention/placebo
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 - Changes in plasma concentration of ferritin, hepcidin, transferrin receptor before and after administration of the intervention/placebo
Timepoint [5] 0 0
Baseline, 30, 60, 90, 120, and 150 minutes
Secondary outcome [6] 0 0
Correlation with body fat phenotypes - Differences in the association between rate of change in plasma glucose concentration and magnetic resonance imaging-derived visceral fat volume in the intervention/placebo
Timepoint [6] 0 0
150 minutes
Secondary outcome [7] 0 0
Correlation with body fat phenotypes - Differences in the association between rate of change in plasma glucose concentration and magnetic resonance imaging-derived subcutaneous fat volume in the intervention/placebo
Timepoint [7] 0 0
150 minutes
Secondary outcome [8] 0 0
Correlation with body fat phenotypes - Differences in the association between rate of change in plasma glucose concentration and magnetic resonance imaging-derived liver fat per centage in the intervention/placebo
Timepoint [8] 0 0
150 minutes
Secondary outcome [9] 0 0
Correlation with physical activity - Differences in the association between rate of change in plasma glucose concentration and metabolic equivalents score in the intervention/placebo
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
The study aims to investigate changes in blood glucose metabolism after administration of a
ketone ester drink.
Trial website
https://clinicaltrials.gov/show/NCT03889210
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

Summary results
Other publications