Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06054035
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2023-09-06
Brief Title:
SGLT2 Inhibition in Addition to Lifestyle Intervention and Risk for Complications in Subtypes of Patients With Prediabetes
Sponsor:
University Hospital Tuebingen
Organization:
University Hospital Tuebingen
Study Overview
Official Title:
SGLT2 Inhibition in Addition to Lifestyle Intervention and Risk for Complications in Subtypes of Patients With Prediabetes - a Randomized Placebo Controlled Multi-center Trial
Status:
RECRUITING
Status Verified Date:
2023-09
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:
More than 50 of patients with type 2 diabetes develop micro- andor macrovascular complications during the course of the disease Additionally many patients at risk for diabetes develop metabolically driven complications including kidney and heart disease Novel sub-phenotyping analysis identified clusters of risk for diabetes associated with different complications mainly affecting the kidneys opening opportunities to new therapeutic approaches despite and in addition to lifestyle changes So far pharmacological therapy is not indicated for patients with prediabetes SGLT2 inhibitors reduce progression of diabetic nephropathy and ischemic heart disease in patients with diabetes and high cardiovascular risk in patients with heart failure with reduced ejection fraction and in individuals with advanced CKD Yet no prospective data are available in patients with prediabetes and beginning chronic kidney disease reflected by normal or modestly reduced GFR and increased uACR 30mgg KDIGO G1A2 - G2A2
Subphenotyping of patients with newly onset diabetes suggests that for some individuals it would be too late to start interventions against deteriorating renal function at the time of diagnosis of type 2 diabetes Therefore individuals at the highest risk to develop T2D and renal failure should receive preventive measures well before the diagnosis of T2D This study will provide evidence whether such an early intervention contributes to the preservation of renal function in high-risk individuals who already have microalbuminuria The studied population will comprise individuals who are likely to develop T2D and nephropathy but in clinical practice do not receive medical treatment due to the early stage of the disease Thereese subjects will receive Dapagliflozin 10 mg or Placebo for two years The placebo treatment arm reflects current practice In order guarantee a benefit the patients in the placebo arm will receive a lifestyle intervention
Subphenotyping of patients with newly onset diabetes suggests that for some individuals it would be too late to start interventions against deteriorating renal function at the time of diagnosis of type 2 diabetes Therefore individuals at the highest risk to develop T2D and renal failure should receive preventive measures well before the diagnosis of T2D This study will provide evidence whether such an early intervention contributes to the preservation of renal function in high-risk individuals who already have microalbuminuria The studied population will comprise individuals who are likely to develop T2D and nephropathy but in clinical practice do not receive medical treatment due to the early stage of the disease Thereese subjects will receive Dapagliflozin 10 mg or Placebo for two years The placebo treatment arm reflects current practice In order guarantee a benefit the patients in the placebo arm will receive a lifestyle intervention
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