Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity

Last updated: November 20, 2024
Sponsor: Gødstrup Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stress

High Blood Pressure (Hypertension)

Circulation Disorders

Treatment

Placebo

Ketone Monoester (KE4)

Beta-hydroxybutyrate

Clinical Study ID

NCT06418074
TZL-1-2024
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 19
Treatment Group(s): 3
Primary Treatment: Placebo
Phase:
Study Start date:
September 11, 2024
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • The University Clinic in Nephrology and Hypertension, Gødstrup Region Hospital

    Herning, 7400
    Denmark

    Active - Recruiting

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