β-hydroxybutyrate, Glucose Metabolism and Prediabetes (CETUS)

University of Auckland, New Zealand

Status: Completed

Conditions: PreDiabetes

Treatments: Other: Placebo; Other: HVMN Ketone

Study type: Interventional

Funder types: Other

Identifiers

NCT03889210

18/NTB/161

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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18 participants in 2 patient groups, including a placebo group

HVMN ketone drink

Active Comparator group

Description:

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

Treatment:

Other: HVMN Ketone

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo