Trials
Search / Trial NCT06418074

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

Launched by GØDSTRUP HOSPITAL · May 13, 2024

Trial Information

Current as of February 12, 2025

Recruiting

Keywords

Natriuresis Kidney Circulation Kidney Physiology Glomerular Filtration Rate

ClinConnect Summary

This clinical trial is looking at how a special treatment called ketone bodies may affect kidney function, blood flow to the kidneys, and the ability of the body to get rid of salt in people with high blood pressure, known as essential hypertension. Nineteen participants will take either the ketone treatment or a placebo (a treatment that has no effect) for five days, followed by a short break before switching to the other treatment. Researchers will measure various effects on kidney function after each treatment period to see if there's a difference.

To be eligible for this study, participants should be between 65 and 74 years old, have essential hypertension that is managed with a maximum of two blood pressure medications, and have normal kidney function. Women who can become pregnant must use safe contraception. Those who have diabetes, heart failure, liver disease, or are pregnant or breastfeeding, among other conditions, cannot participate. If you join the trial, you'll help researchers understand the potential benefits of ketone bodies for kidney health in people with high blood pressure.

Gender

ALL

Eligibility criteria

  • 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 Officials

Trine Z Lyksholm, MD

Principal Investigator

The University Clinic for Nephrology and Hypertenion, Regional Hospital Godstrup

About Gødstrup Hospital

Gødstrup Hospital is a leading healthcare institution dedicated to advancing medical research and improving patient outcomes through innovative clinical trials. As a prominent sponsor, the hospital focuses on a wide range of therapeutic areas, fostering collaboration among multidisciplinary teams to ensure rigorous study design and ethical standards. Committed to enhancing the quality of care, Gødstrup Hospital integrates cutting-edge technology and evidence-based practices in its research initiatives, aiming to translate scientific discoveries into tangible benefits for patients and the broader community.

Locations

Herning, , Denmark

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0