Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418074
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-06
Brief Title:
Effects of Exogenous Ketosis on Renal Function Renal Perfusion and Sodium Excretory Capacity
Sponsor:
Gødstrup Hospital
Organization:
Gødstrup Hospital
Study Overview
Official Title:
Effects of Exogenous Ketosis on Renal Function Renal Perfusion and Sodium Excretory Capacity in Patients With Essential Hypertension
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KETO-HT
Brief 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
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 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 TechnetiumTc99m - Diethylenetriamine pentaacetate DTPA clearance and water based positron emission tomography computed tomography PETCT
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
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 TechnetiumTc99m - Diethylenetriamine pentaacetate DTPA clearance and water based positron emission tomography computed tomography PETCT
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None