Trial Review

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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
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
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
The study aims to investigate changes in blood glucose metabolism after administration of a ketone ester drink.
Trial website
https://clinicaltrials.gov/study/NCT03889210
Trial related presentations / publications
Liu Y, Bharmal SH, Kimita W, Petrov MS. Effect of acute ketosis on lipid profile in prediabetes: findings from a cross-over randomized controlled trial. Cardiovasc Diabetol. 2022 Jul 23;21(1):138. doi: 10.1186/s12933-022-01571-z.
Bharmal SH, Alarcon Ramos GC, Ko J, Petrov MS. Abdominal fat distribution modulates the metabolic effects of exogenous ketones in individuals with new-onset prediabetes after acute pancreatitis: Results from a randomized placebo-controlled trial. Clin Nutr ESPEN. 2021 Jun;43:117-129. doi: 10.1016/j.clnesp.2021.03.013. Epub 2021 Mar 21.
Bharmal SH, Cho J, Alarcon Ramos GC, Ko J, Cameron-Smith D, Petrov MS. Acute Nutritional Ketosis and Its Implications for Plasma Glucose and Glucoregulatory Peptides in Adults with Prediabetes: A Crossover Placebo-Controlled Randomized Trial. J Nutr. 2021 Apr 8;151(4):921-929. doi: 10.1093/jn/nxaa417.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03889210