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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketone Monoester (KE4), then Placebo drink | Active Comparator | 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. |
|
| Placebo drink, then Ketone Monoester (KE4) | Placebo Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketone Monoester (KE4) | Dietary Supplement | Each subject will receive beta-hydroxybutyrate boned to R 1,3 Butandiol (KE4) 300mg/kg x 3 for five days. After the treatment period effect variables will be examined. |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour systolic blood pressure | Change in systolic 24-hour blood pressure | Measured after each treatment period (each treatment period is 6 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Renal Blood Flow (RBF) | Change in RBF determined by water based PET/CT scans | Measured after each treatment period (each treatment period is 6 days) |
| GFR | Change in GFR measured by Tc99m-DTPA clearance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Trine Z Lyksholm, MD | The University Clinic for Nephrology and Hypertenion, Regional Hospital Godstrup | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University Clinic in Nephrology and Hypertension, Gødstrup Region Hospital | Herning | 7400 | Denmark |
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| ID | Term |
|---|---|
| D007662 | Ketosis |
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Other | Each subject will receive a placebo drink 3 x day for five days. After the treatment period effect variables will be examined. |
|
| Measured after each treatment period (each treatment period is 6 days) |
| Vasoactive hormones | Change in plasma levels of aldosterone, renin, brain natriuretic peptide (BNP), atrial natriuretic peptide (ANP), copeptin | Measured after each treatment period (each treatment period is 6 days) |
| P-Beta-hydroxybutyrate | Change ind p-beta-hydroxybutyrate concentration | Measured after each treatment period (each treatment period is 6 days) |
| Plasma concentration of renal tubular transport proteins | Urine excretions of aquaporin 2 (AQP2), thiazide-sensitive sodium-chloride cotransporter (NCC) and distal epithelial sodium channel (ENaC) | Measured after each treatment period (each treatment period is 6 days) |
| D006973 |
| Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |