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β-hydroxybutyrate, Glucose Metabolism and Prediabetes (CETUS)

Primary Purpose

PreDiabetes

Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
HVMN Ketone
Placebo
Sponsored by
University of Auckland, New Zealand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PreDiabetes focused on measuring Ketones, Prediabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

  • University of Auckland; Auckland City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

HVMN ketone drink

Placebo

Arm Description

HVMN ketone drink will be given in a total volume of 100 ml.

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

Outcomes

Primary Outcome Measures

Rate of change in plasma glucose concentration
Changes in plasma glucose concentration before and after administration of the intervention/placebo

Secondary Outcome Measures

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
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
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
Rate of change in plasma concentration of pro-inflammatory cytokines
Changes in plasma concentration of interleukin-1β, interleukin-6, leptin, tumor necrosis factor α, and monocyte chemoattractant protein-1 and other cytokines before and after administration of the intervention/placebo
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
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
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
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
Correlation with physical activity
Differences in the association between rate of change in plasma glucose concentration and metabolic equivalents score in the intervention/placebo

Full Information

First Posted
March 18, 2019
Last Updated
November 4, 2019
Sponsor
University of Auckland, New Zealand
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1. Study Identification

Unique Protocol Identification Number
NCT03889210
Brief Title
β-hydroxybutyrate, Glucose Metabolism and Prediabetes
Acronym
CETUS
Official Title
Cross-over, Placebo-controlled, Randomized Trial of β-hydroxybutyrate in Prediabetes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
August 16, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Auckland, New Zealand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study aims to investigate changes in blood glucose metabolism after administration of a ketone ester drink.
Detailed Description
New-onset prediabetes is the most significant risk factor for diabetes. Clinical studies in healthy human volunteers have demonstrated that ketone esters lower blood glucose levels in both fasting and fed state. Participants will visit the COSMOS clinic on two occasions and will be randomly allocated to receive either the HVMN ketone drink or placebo, in a cross-over design. Blood samples will be collected sequentially every 30 minutes for up to 150 minutes. Blood samples will be assayed for glucose and other markers of glucose metabolism.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes
Keywords
Ketones, Prediabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HVMN ketone drink
Arm Type
Active Comparator
Arm Description
HVMN ketone drink will be given in a total volume of 100 ml.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be given in a total volume of 100 ml.
Intervention Type
Other
Intervention Name(s)
HVMN Ketone
Intervention Description
Water-based, flavoured sport beverage
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Water, stevia, malic acid, and thickening agent
Primary Outcome Measure Information:
Title
Rate of change in plasma glucose concentration
Description
Changes in plasma glucose concentration before and after administration of the intervention/placebo
Time Frame
Baseline, 30, 60, 90, 120, and 150 minutes
Secondary Outcome Measure Information:
Title
Rate of change in plasma insulin and C-peptide concentrations
Description
Changes in plasma insulin and C-peptide concentrations before and after administration of the intervention/placebo
Time Frame
Baseline, 30, 60, 90, 120, and 150 minutes
Title
Rate of change in plasma concentration of gut and pancreatic hormones
Description
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
Time Frame
Baseline, 30, 60, 90, 120, and 150 minutes
Title
Rate of change in lipid profile and digestive enzymes
Description
Changes in plasma concentration of triglycerides, glycerol, cholesterol, lipases before and after administration of the intervention/placebo
Time Frame
Baseline, 30, 60, 90, 120, and 150 minutes
Title
Rate of change in plasma concentration of pro-inflammatory cytokines
Description
Changes in plasma concentration of interleukin-1β, interleukin-6, leptin, tumor necrosis factor α, and monocyte chemoattractant protein-1 and other cytokines before and after administration of the intervention/placebo
Time Frame
Baseline, 30, 60, 90, 120, and 150 minutes
Title
Rate of change in plasma concentration of markers of iron metabolism
Description
Changes in plasma concentration of ferritin, hepcidin, transferrin receptor before and after administration of the intervention/placebo
Time Frame
Baseline, 30, 60, 90, 120, and 150 minutes
Title
Correlation with body fat phenotypes
Description
Differences in the association between rate of change in plasma glucose concentration and magnetic resonance imaging-derived visceral fat volume in the intervention/placebo
Time Frame
150 minutes
Title
Correlation with body fat phenotypes
Description
Differences in the association between rate of change in plasma glucose concentration and magnetic resonance imaging-derived subcutaneous fat volume in the intervention/placebo
Time Frame
150 minutes
Title
Correlation with body fat phenotypes
Description
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
Time Frame
150 minutes
Title
Correlation with physical activity
Description
Differences in the association between rate of change in plasma glucose concentration and metabolic equivalents score in the intervention/placebo
Time Frame
150 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Facility Information:
Facility Name
University of Auckland; Auckland City Hospital
City
Auckland
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35871064
Citation
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.
Results Reference
derived
PubMed Identifier
34024503
Citation
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.
Results Reference
derived
PubMed Identifier
33561274
Citation
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.
Results Reference
derived

Learn more about this trial

β-hydroxybutyrate, Glucose Metabolism and Prediabetes

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