β-hydroxybutyrate, Glucose Metabolism and Prediabetes
- Conditions
- PreDiabetes
- Interventions
- Other: HVMN KetoneOther: Placebo
- Registration Number
- NCT03889210
- Lead Sponsor
- University of Auckland, New Zealand
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description HVMN ketone drink HVMN Ketone HVMN ketone drink will be given in a total volume of 100 ml. Placebo Placebo Placebo will be given in a total volume of 100 ml.
- Primary Outcome Measures
Name Time Method Rate of change in plasma glucose concentration Baseline, 30, 60, 90, 120, and 150 minutes Changes in plasma glucose concentration before and after administration of the intervention/placebo
- Secondary Outcome Measures
Name Time Method Rate of change in lipid profile and digestive enzymes 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
Correlation with body fat phenotypes 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
Correlation with physical activity 150 minutes Differences in the association between rate of change in plasma glucose concentration and metabolic equivalents score in the intervention/placebo
Rate of change in plasma concentration of markers of iron metabolism 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
Rate of change in plasma concentration of gut and pancreatic hormones 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
Rate of change in plasma insulin and C-peptide concentrations Baseline, 30, 60, 90, 120, and 150 minutes Changes in plasma insulin and C-peptide concentrations before and after administration of the intervention/placebo
Rate of change in plasma concentration of pro-inflammatory cytokines 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
Trial Locations
- Locations (1)
University of Auckland; Auckland City Hospital
🇳🇿Auckland, New Zealand