Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity ((KETO-HT))

Gødstrup Hospital

Status: Enrolling

Conditions: Ketosis; Essential Hypertension

Treatments: Dietary Supplement: Ketone Monoester (KE4); Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06418074

TZL-1-2024

Details and patient eligibility

About

This is a randomized, placebo-controlled, double-blinded crossover design. Nineteen patients with essential hypertension will be randomized to receive either ketone bodies (KE4) or placebo delivered by KetoneAid. After a period of 5-days treatment, effect variables will be measured (experiment day 1). After a washout period of 14 days, the subjects are crossed over to a similar treatment period with the other treatment. The study is terminated by measuring effect variables after the second treatment period (experiment day 2).

Full description

Background: Renewed interest in ketone bodies has emerged, partly driven by the recent success of selective sodium glucose co transporter 2 (SGLT-2) inhibition in preventing cardiovascular deaths in patients with diabetes mellitus (DM) and chronic kidney disease (CKD). Effects of ketosis are of importance in order to understand the beneficial effects of SGLT-2 inhibitors and to account for the full therapeutic potential of this treatment.

Hypothesis: Ketosis decreases 24 hour systolic blood pressure and increases renal blood flow and glomerular filtration rate (GFR).

Methods: It is a randomized, placebo-controlled double-blinded cross over study. Nineteen patients with essential hypertension will be randomized to receive either ketone bodies (KE4) or for 5 days. After a wash out period of at least 14 days, the subjects are crossed over to receive the other treatment. After each treatment period effect variables will be measured including Technetium(Tc)99m - Diethylenetriamine pentaacetate (DTPA) clearance and water based positron emission tomography computed tomography (PET/CT)

Perspectives: The study has the potential to provide information regarding the therapeutic potential of treatment with ketone bodies and understanding of conditions characterized by ketosis, such as SGLT2-inhibitor treatment.

Enrollment: 19 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Essential hypertension (treatment with maximum 2 antihypertensive drugs)
• eGFR > 60ml/min
• BMI < 35 kg/m2
• Urine Albumin Creatinin Ratio (UACR) < 300mg/g
• Safe contraception if women in childbearing age

Exclusion criteria

• Diabetes type 1 or 2
• Heart Failure
• Pregnancy or breast feeding
• Liver disease
• Malignant disease
• Recent acute myocardial infarction (AMI), apoplexia/transient ischemic attack (TIA) (within 12 months of inclusion)
• Daily use of prescription drugs (expect for contraceptives)
• Alcohol or drug abuse
• Periodic fasting
• Routinely intake of ketogenic diet
• Treatment with immunosuppressants or SGLT2-inhibitors

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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19 participants in 2 patient groups, including a placebo group

Ketone Monoester (KE4), then Placebo drink

Active Comparator group

Description:

For five days each subject will receive beta-hydroxybutyrate boned to R 1,3 Butandiol (KE4), then crossed over to receive placebo drink for 5 days.

Treatment:

Other: Placebo

Dietary Supplement: Ketone Monoester (KE4)

Placebo drink, then Ketone Monoester (KE4)

Placebo Comparator group

Description:

For five days each subject will receive a placebo drink three times daily, then subjects are crossed over to receive beta-hydroxybutyrate boned to R 1,3 Butandiol (KE4).

Treatment:

Other: Placebo

Dietary Supplement: Ketone Monoester (KE4)