SGLT2 Inhibition in Addition to Lifestyle Intervention & Risk for

Status Not yet recruiting

Clinical Trial Summary

More than 50% of patients with type 2 diabetes develop micro- and/or 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 (> 30mg/g, 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06054035
Study type	Interventional
Source	University Hospital Tuebingen
Contact	Andreas Birkenfeld, Prof. Dr.
Phone	0049707129
Email	andreas.birkenfeld@med.uni-tuebingen.de
Status	Not yet recruiting
Phase	Phase 4
Start date	October 15, 2023
Completion date	December 31, 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05354245` - Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL)	N/A
Completed	`NCT03644524` - Heat Therapy and Cardiometabolic Health in Obese Women	N/A
Recruiting	`NCT06007404` - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting	`NCT06115265` - Ketogenic Diet and Diabetes Demonstration Project	N/A
Completed	`NCT03188263` - Morning Light Treatment to Improve Glucose Metabolism	N/A
Recruiting	`NCT03821961` - 18F-FDOPA PET/CT Imaging in Patients Undergoing Metabolic Surgery	N/A
Completed	`NCT04303468` - Intervention With a GABA Supplement in Prediabetics	N/A
Recruiting	`NCT06094231` - Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study	N/A
Completed	`NCT03675360` - Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial	N/A
Completed	`NCT01910051` - Explorative Assessment of Biomarkers in Overweight and Obese Subjects
Completed	`NCT03527368` - The Time-Restricted Intake of Meals Study	N/A
Completed	`NCT03865342` - Prevention of Diabetes Using Mobile-enabled, Virtual Delivery of the National Diabetes Prevention Program	N/A
Suspended	`NCT03240978` - Exercise Intervention for the Prevention of Prediabetes in Overweight Chinese	N/A
Completed	`NCT02899390` - Diabetes Prevention Program in Adults of the Yaqui Tribe of Hermosillo, Sonora at Risk of Diabetes	N/A
Recruiting	`NCT01972113` - Vitamin K and Glucose Metabolism in Children at Risk for Diabetes (Vita-K 'n' Kids Study)	N/A
Completed	`NCT01436916` - Oral Cholecalciferol in Prevention of Type 2 Diabetes Mellitus	Phase 4
Completed	`NCT01432509` - Prospective Follow-up of a Cohort of Pre-diabetics in the North of France (DiabeNord)	N/A
Completed	`NCT00990184` - Study to Evaluate the Effects of Colesevelam on Insulin Sensitivity and ß-Cell Function in Subjects With Impaired Fasting Glucose (Prediabetes)	Phase 3
Completed	`NCT00886340` - A Lifestyle Change Program to Prevent Type 2 Diabetes	Phase 2
Not yet recruiting	`NCT05658770` - Efficacy of Physical Exercise on Glucose Control in People With Prediabetes (GLYCEX) - Phase II	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

SGLT2 Inhibition in Addition to Lifestyle Intervention and Risk for Complications in Subtypes of Patients With Prediabetes

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms