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Completed

NCT Number: NCT03889210

β-hydroxybutyrate, Glucose Metabolism and Prediabetes

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

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Key information

Conditions

PreDiabetes Acid-Base Imbalance Acidosis Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Ketosis Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Auckland; Auckland City Hospital

Auckland, New Zealand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HVMN Ketone

Other

Water-based, flavoured sport beverage

Placebo

Other

Water, stevia, malic acid, and thickening agent

Primary outcomes

  1. Rate of change in plasma glucose concentration

    Time frame: Baseline, 30, 60, 90, 120, and 150 minutes

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

Secondary outcomes

  1. Rate of change in plasma insulin and C-peptide concentrations

    Time frame: Baseline, 30, 60, 90, 120, and 150 minutes

    Changes in plasma insulin and C-peptide concentrations before and after administration of the intervention/placebo

  2. Rate of change in plasma concentration of gut and pancreatic hormones

    Time frame: Baseline, 30, 60, 90, 120, and 150 minutes

    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

  3. Rate of change in lipid profile and digestive enzymes

    Time frame: Baseline, 30, 60, 90, 120, and 150 minutes

    Changes in plasma concentration of triglycerides, glycerol, cholesterol, lipases before and after administration of the intervention/placebo

  4. Rate of change in plasma concentration of pro-inflammatory cytokines

    Time frame: Baseline, 30, 60, 90, 120, and 150 minutes

    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

  5. Rate of change in plasma concentration of markers of iron metabolism

    Time frame: Baseline, 30, 60, 90, 120, and 150 minutes

    Changes in plasma concentration of ferritin, hepcidin, transferrin receptor before and after administration of the intervention/placebo

  6. Correlation with body fat phenotypes

    Time frame: 150 minutes

    Differences in the association between rate of change in plasma glucose concentration and magnetic resonance imaging-derived visceral fat volume in the intervention/placebo

  7. Correlation with body fat phenotypes

    Time frame: 150 minutes

    Differences in the association between rate of change in plasma glucose concentration and magnetic resonance imaging-derived subcutaneous fat volume in the intervention/placebo

  8. Correlation with body fat phenotypes

    Time frame: 150 minutes

    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

  9. Correlation with physical activity

    Time frame: 150 minutes

    Differences in the association between rate of change in plasma glucose concentration and metabolic equivalents score in the intervention/placebo

Sponsors and collaborators

Lead sponsor

University of Auckland, New Zealand

Other

Registry information

Official study title

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

Acronym: CETUS

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 26, 2019
Registry last updated
Nov 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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