NCT03889210: CETUS

β-hydroxybutyrate, Glucose Metabolism and Prediabetes

Completed NA Last updated 6 November 2019

What this trial tests

NA trial testing HVMN Ketone in PreDiabetes in 18 participants. Completed in 30 August 2019.

Timeline

1 April 2019

Primary endpoint
16 August 2019

30 August 2019

Quick facts

Lead sponsor	University of Auckland, New Zealand
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	prevention
Enrollment	18
Start date	1 April 2019
Primary completion	16 August 2019
Estimated completion	30 August 2019
Sites	1 location across New Zealand

Drugs / interventions tested

• HVMN Ketone
• Placebo

Conditions studied

• PreDiabetes — all drugs for PreDiabetes →

Sponsor

University of Auckland, New Zealand

Who can join

18 and older, any sex, with PreDiabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study aims to investigate changes in blood glucose metabolism after administration of a ketone ester drink.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ketone Administration for Seizure Disorders: History and Rationale for Ketone Esters and Metabolic Alternatives.
   Poff AM, Rho JM, D'Agostino DP. · · 2019 · cited 52× · PMID 31680801 · DOI 10.3389/fnins.2019.01041
2. Acute Nutritional Ketosis and Its Implications for Plasma Glucose and Glucoregulatory Peptides in Adults with Prediabetes: A Crossover Placebo-Controlled Randomized Trial.
   Bharmal SH, Cho J, Alarcon Ramos GC, Ko J, et al · · 2021 · cited 17× · PMID 33561274 · DOI 10.1093/jn/nxaa417
3. Effect of acute ketosis on lipid profile in prediabetes: findings from a cross-over randomized controlled trial.
   Liu Y, Bharmal SH, Kimita W, Petrov MS. · · 2022 · cited 12× · PMID 35871064 · DOI 10.1186/s12933-022-01571-z
4. 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.
   Bharmal SH, Alarcon Ramos GC, Ko J, Petrov MS. · · 2021 · cited 8× · PMID 34024503 · DOI 10.1016/j.clnesp.2021.03.013
5. Effect of d-β-Hydroxybutyrate-(R)-1,3 Butanediol on Appetite Regulation in People with Prediabetes.
   Liu Y, Bharmal SH, Kimita W, Petrov MS. · · 2023 · cited 6× · PMID 36565045 · DOI 10.1002/mnfr.202200615
6. Effect of D-β-hydroxybutyrate-(<i>R</i>)-1,3 butanediol on plasma levels of asprosin and leptin: results from a randomised controlled trial.
   Charles S, Liu Y, Kimita W, Ko J, et al · · 2023 · cited 5× · PMID 36594212 · DOI 10.1039/d2fo02405e
7. Response to lowering plasma glucose is characterised by decreased oxyntomodulin: Results from a randomised controlled trial.
   Liu Y, Kimita W, Bharmal SH, Petrov MS. · · 2024 · cited 3× · PMID 38901179 · DOI 10.1016/j.dsx.2024.103052
8. Effect of Acute Nutritional Ketosis on Circulating Levels of Growth Differentiation Factor 15: Findings from a Cross-Over Randomised Controlled Trial.
   Charles S, Liu Y, Bharmal SH, Kimita W, et al · · 2024 · cited 2× · PMID 38927068 · DOI 10.3390/biom14060665