β-hydroxybutyrate, Glucose Metabolism and Prediabetes

PreDiabetes Clinical Trial

— CETUS  

Official title:

Cross-over, Placebo-controlled, Randomized Trial of β-hydroxybutyrate in Prediabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03889210
• Other study ID #: 18/NTB/161
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: August 30, 2019

Study information

• Verified date: November 2019
• Source: University of Auckland, New Zealand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 30, 2019
• Est. primary completion date: August 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

Other:
• HVMN Ketone
Water-based, flavoured sport beverage
• Placebo
Water, stevia, malic acid, and thickening agent

Locations

Country	Name	City	State
New Zealand	University of Auckland; Auckland City Hospital	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
University of Auckland, New Zealand

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Baseline, 30, 60, 90, 120, and 150 minutes
Secondary	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	Baseline, 30, 60, 90, 120, and 150 minutes
Secondary	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	Baseline, 30, 60, 90, 120, and 150 minutes
Secondary	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	Baseline, 30, 60, 90, 120, and 150 minutes
Secondary	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	Baseline, 30, 60, 90, 120, and 150 minutes
Secondary	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	150 minutes
Secondary	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	150 minutes
Secondary	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	150 minutes
Secondary	Correlation with physical activity	Differences in the association between rate of change in plasma glucose concentration and metabolic equivalents score in the intervention/placebo	150 minutes