Clinical trial NCT05980858: Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity in Healthy Subjects
Official title: Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ketosis
Ketonemia
Keywords: Kidney circulation
Kidney physiology
Kidney function
Glomerular Filtration Rate
Lead sponsor: Gødstrup Hospital
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a randomized, placebo-controlled, double-blinded crossover design. Fifteen healthy subjects 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).

Detailed 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 increases renal blood flow and glomerular filtration rate (GFR).

Methods: It is a randomized, placebo-controlled double-blinded cross over study. Fifteen healthy subjects 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.

Eligibility criteria: Inclusion Criteria:

* BMI \< 30 kg/m2
* Safe contraception if women in childbearing age
* Normal biochemical screening

Exclusion Criteria:

* Pregnancy or breast feeding
* Major heart-, liver-, kidney-, lung-, neurological- or endocrine disease
* Daily use of prescription drugs (expect for contraceptives)
* Alcohol or drug abuse
* Periodic fasting
* Routinely intake of ketogenic diet

Primary outcomes:
measure: GFR
timeFrame: Measured after each treatment period (day 6 and approximately day 26)
measure: Renal Blood Flow (RBF)
timeFrame: Subjects are scanned after each treatment period (day 6 and approximately day 26)
Secondary outcomes:
measure: 24-hour blood pressure
timeFrame: Measured after each treatment period (day 6 and approximately day 26)
measure: Vasoactive hormones
timeFrame: Measured after each treatment period (day 6 and approximately day 26)
measure: Beta-hydroxybutyrate
timeFrame: Measured after each treatment period (day 6 and approximately day 26)
measure: Renal tubular transport proteins
timeFrame: Measured after each treatment period (day 6 and approximately day 26)
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: The University Clinic of Nephrology and Hypertension
state: Jutland
Study officials:
affiliation: University Clinic in Nephrology and Hypertension
name: Jesper N Bech, PhD, Prof
role: PRINCIPAL_INVESTIGATOR
References: