β-hydroxybutyrate, Glucose Metabolism and Prediabetes
CETUS
Cross-over, Placebo-controlled, Randomized Trial of β-hydroxybutyrate in Prediabetes
1 other identifier
interventional
18
1 country
1
Brief Summary
The study aims to investigate changes in blood glucose metabolism after administration of a ketone ester drink.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2019
CompletedFirst Posted
Study publicly available on registry
March 26, 2019
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2019
CompletedNovember 6, 2019
November 1, 2019
5 months
March 18, 2019
November 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of change in plasma glucose concentration
Changes in plasma glucose concentration before and after administration of the intervention/placebo
Baseline, 30, 60, 90, 120, and 150 minutes
Secondary Outcomes (9)
Rate of change in plasma insulin and C-peptide concentrations
Baseline, 30, 60, 90, 120, and 150 minutes
Rate of change in plasma concentration of gut and pancreatic hormones
Baseline, 30, 60, 90, 120, and 150 minutes
Rate of change in lipid profile and digestive enzymes
Baseline, 30, 60, 90, 120, and 150 minutes
Rate of change in plasma concentration of pro-inflammatory cytokines
Baseline, 30, 60, 90, 120, and 150 minutes
Rate of change in plasma concentration of markers of iron metabolism
Baseline, 30, 60, 90, 120, and 150 minutes
- +4 more secondary outcomes
Study Arms (2)
HVMN ketone drink
ACTIVE COMPARATORHVMN ketone drink will be given in a total volume of 100 ml.
Placebo
PLACEBO COMPARATORPlacebo will be given in a total volume of 100 ml.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Auckland; Auckland City Hospital
Auckland, New Zealand
Related Publications (6)
Charles S, Liu Y, Bharmal SH, Kimita W, Petrov MS. Effect of Acute Nutritional Ketosis on Circulating Levels of Growth Differentiation Factor 15: Findings from a Cross-Over Randomised Controlled Trial. Biomolecules. 2024 Jun 6;14(6):665. doi: 10.3390/biom14060665.
PMID: 38927068DERIVEDCharles S, Liu Y, Kimita W, Ko J, Bharmal SH, Petrov MS. Effect of D-beta-hydroxybutyrate-(R)-1,3 butanediol on plasma levels of asprosin and leptin: results from a randomised controlled trial. Food Funct. 2023 Jan 23;14(2):759-768. doi: 10.1039/d2fo02405e.
PMID: 36594212DERIVEDLiu Y, Bharmal SH, Kimita W, Petrov MS. Effect of d-beta-Hydroxybutyrate-(R)-1,3 Butanediol on Appetite Regulation in People with Prediabetes. Mol Nutr Food Res. 2023 Feb;67(4):e2200615. doi: 10.1002/mnfr.202200615. Epub 2023 Jan 26.
PMID: 36565045DERIVEDLiu 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.
PMID: 35871064DERIVEDBharmal 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.
PMID: 34024503DERIVEDBharmal 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.
PMID: 33561274DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 18, 2019
First Posted
March 26, 2019
Study Start
April 1, 2019
Primary Completion
August 16, 2019
Study Completion
August 30, 2019
Last Updated
November 6, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share