The Effect of a Ketone Drink on Blood Glucose Levels in People With Type 2 Diabetes

University of Exeter15 enrolled

Overview

Ketones are naturally produced by our body and can affect our blood sugar levels. Ketones could be important in the treatment of type 2 diabetes (T2D). The purpose of this research is to determine if a ketone drink can lower blood sugar in people with T2D following a meal. This research will provide new knowledge about the regulation of blood sugar. This may also inform if ketone drinks could be used as a treatment for T2D.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Type 2 Diabetes

Interventions

Ketone supplementDIETARY_SUPPLEMENT

100 mL flavoured drink containing 0.3 g/kg ketone monoester ((R)-3-hydroxybutyl (R)-3-hydroxybutyrate; ΔG®, University of Oxford; https://www.deltagketones.com) consumed 30 min prior to a mixed meal tolerance test, on 2 occasions during test day

Placebo supplementDIETARY_SUPPLEMENT

Placebo with stevia and bitter agent to flavour match, consumed 30 min prior to a mixed meal tolerance test, on 2 occasions during test day

Eligibility

Sex: ALLMin age: 41 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged 41-70 years old 2. Body mass index 27-40 mg/m² 3. Type 2 diagnosis for more than 1 year 4. HbA1c \>6% Exclusion Criteria: 1. Currently following ketogenic diet 2. Use of insulin 3. HbA1c \>10% 4. Recent weight loss (\>5kg in 6 months) 5. Recent eGFR \<30mL/min 6. Heart failure 7. Substance abuse 8. Cancer 9. Myocardial infarction within 6 months 10. Pregnancy or consideration of 11. Use of antipsychotic drugs

Locations (1)

Sport & Health Sciences University of Exeter

Exeter, Devon, United Kingdom

Outcomes

Primary Outcomes

Rate of endogenous glucose production

Rate of endogenous glucose production over 4 hours in response to a meal measured by blood sample

Time frame: 4 hours

Secondary Outcomes

Total rate of glucose appearance

Total rate of glucose appearance measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal

Time frame: 4 and 8 hours

Exogenous glucose rate of appearance

Exogenous rate of glucose appearance measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal

Time frame: 4 and 8 hours

Total rate of glucose disappearance

Total rate of glucose disappearance measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal

Time frame: 4 and 8 hours

Rate of gluconeogenesis

Rate of gluconeogenesis measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal

Time frame: 4 and 8 hours

Rate of glycogenolysis

Rate of glycogenolysis measured using the change in glucose enrichment/concentration over 4 and 8 hours following a meal

Time frame: 4 and 8 hours

Beta-cell function

Beta-cell function using dynamic modelling of insulin/c-peptide secretion over 4 and 8 hours following a meal

Time frame: 4 and 8 hours

Data from ClinicalTrials.gov

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