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Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity in Healthy Subjects (KETO)

Primary Purpose

Ketosis, Ketonemia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Beta-hydroxybutyrate
Placebo
Sponsored by
Gødstrup Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ketosis focused on measuring Kidney circulation, Kidney physiology, Kidney function, Glomerular Filtration Rate

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    KetoneAid KE4, then Placebo drink

    Placebo drink, then KetoneAid KE4

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    GFR
    Change in GFR measured by Tc99m-DTPA clearance
    Renal Blood Flow (RBF)
    Change in RBF determined by water based PET/CT scans

    Secondary Outcome Measures

    24-hour blood pressure
    Change in systolic 24-hour blood pressure
    Vasoactive hormones
    Change in plasma levels of angiotensin II, aldosterone, renin, brain natriuretic peptide (BNP), atrial natriuretic peptide (ANP), copeptin
    Beta-hydroxybutyrate
    Change ind p-beta-hydroxybutyrate
    Renal tubular transport proteins
    Urine excretions of aquaporin 2 (AQP2), thiazide-sensitive sodium-chloride cotransporter (NCC) and distal epithelial sodium channel (ENaC)

    Full Information

    First Posted
    July 5, 2023
    Last Updated
    August 16, 2023
    Sponsor
    Gødstrup Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05980858
    Brief Title
    Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity in Healthy Subjects
    Acronym
    KETO
    Official Title
    Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity in Healthy Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gødstrup Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ketosis, Ketonemia
    Keywords
    Kidney circulation, Kidney physiology, Kidney function, Glomerular Filtration Rate

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    KetoneAid KE4, then Placebo drink
    Arm Type
    Active Comparator
    Arm Description
    For five days each subject will receive beta-hydroxybutyrate (KE4), then crossed over to receive placebo drink for 5 days.
    Arm Title
    Placebo drink, then KetoneAid KE4
    Arm Type
    Active Comparator
    Arm Description
    For five days each subject will receive a placebo drink three times daily, then subjects are crossed over to receive beta-hydroxybutyrate (KE4).
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Beta-hydroxybutyrate
    Intervention Description
    Each subject receive Beta-hydroxybutyrate 300mg/kg x 3 for five days. After the treatment period effect variables will be examined.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Each subject receive a placebo drink 3 x day for five days. After the treatment period effect variables will be examined.
    Primary Outcome Measure Information:
    Title
    GFR
    Description
    Change in GFR measured by Tc99m-DTPA clearance
    Time Frame
    Measured after each treatment period (day 6 and approximately day 26)
    Title
    Renal Blood Flow (RBF)
    Description
    Change in RBF determined by water based PET/CT scans
    Time Frame
    Subjects are scanned after each treatment period (day 6 and approximately day 26)
    Secondary Outcome Measure Information:
    Title
    24-hour blood pressure
    Description
    Change in systolic 24-hour blood pressure
    Time Frame
    Measured after each treatment period (day 6 and approximately day 26)
    Title
    Vasoactive hormones
    Description
    Change in plasma levels of angiotensin II, aldosterone, renin, brain natriuretic peptide (BNP), atrial natriuretic peptide (ANP), copeptin
    Time Frame
    Measured after each treatment period (day 6 and approximately day 26)
    Title
    Beta-hydroxybutyrate
    Description
    Change ind p-beta-hydroxybutyrate
    Time Frame
    Measured after each treatment period (day 6 and approximately day 26)
    Title
    Renal tubular transport proteins
    Description
    Urine excretions of aquaporin 2 (AQP2), thiazide-sensitive sodium-chloride cotransporter (NCC) and distal epithelial sodium channel (ENaC)
    Time Frame
    Measured after each treatment period (day 6 and approximately day 26)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Trine Z Lyksholm, MD
    Phone
    28439136
    Ext
    0045
    Email
    trizur@rm.dk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jesper N Bech, PhD, Prof
    Organizational Affiliation
    University Clinic in Nephrology and Hypertension
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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