Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06094231
Status:
RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-10-06
Brief Title:
Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study
Sponsor:
Department of Nephrology Clinic Ottakring Vienna
Organization:
Department of Nephrology Clinic Ottakring Vienna
Study Overview
Official Title:
Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study
Status:
RECRUITING
Status Verified Date:
2023-10
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:
None
Brief Summary:
This randomized controlled trail will evaluate the efficacy and safety of a simultaneous therapeutic carbohydrate restriction and treatment with the Sodium-Glucose-Transporter-2-Inhibitor dapagliflozin in comparison to the standard of care treatment in patients with chronic kidney disease and prediabetes or type 2 diabetes mellitus
Participants will be randomized 11 The interventional group will be educated on how to implement a therapeutic carbohydrate restriction 50-100 grams of carbohydrates per day Regarding safety the patients of the interventional group will be provided with continuous glucose monitoring systems and blood ketone meters The participants of the control group will continue to receive the standard of care therapy for the treatment of chronic kidney disease and prediabetes or type 2 diabetes mellitus Both groups will be treated with dapagliflozin
Participants will be randomized 11 The interventional group will be educated on how to implement a therapeutic carbohydrate restriction 50-100 grams of carbohydrates per day Regarding safety the patients of the interventional group will be provided with continuous glucose monitoring systems and blood ketone meters The participants of the control group will continue to receive the standard of care therapy for the treatment of chronic kidney disease and prediabetes or type 2 diabetes mellitus Both groups will be treated with dapagliflozin
Detailed Description:
None
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