PreDiabetes
Conditions
Keywords
Ketones, Prediabetes
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.
Interventions
OTHERHVMN Ketone
Water-based, flavoured sport beverage
OTHERPlacebo
Water, stevia, malic acid, and thickening agent
Sponsors
University of Auckland, New Zealand
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
| 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 |
| Correlation with body fat phenotypes | 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 |
| 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 |
Countries
New Zealand
Outcome results
None listed