NCT05417646

Impact of SGLT2 on Glucosuria in HNF1A-MODY

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Steno Diabetes Center Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Maturity onset diabetes of the young (MODY) is a subtype of diabetes which is caused by mutations in specific genes leading to diabetes. The most common cause of MODY is due to mutations in the gene hepatocyte nuclear factor 1 alpha (HNF1A) and is consequently named HNF1A-MODY (or MODY3). HNF1A-MODY is associated with urinary excretion of glucose at lower blood glucose levels compared to other types of diabetes. Normally, glucose is reabsorbed by sodium-glucose cotransporter 2 (SGLT2), but SGLT2 is downregulated due to the mutation in HNF1A. Investigators aim to evaluate the impact of the decreased expression of SGLT2 on glucosuria in patients with HNF1A-MODY compared to patients with type 2 diabetes (T2D) using a single dose of an SGLT2 inhibitor during a glucose clamp experiment.

Detailed description

Participants: Patients with HNF1A-MODY (n=12) and patients with T2D (n=12)

Conditions

• Maturity-Onset Diabetes of the Young, Type 3
• Type 2 Diabetes

Interventions

Type	Name	Description
OTHER	Hyperglycaemic clamp	Three-hour, three-step glucose clamp with plasma glucose targets 10, 14 and 18 mmol/l (each one hour)
DRUG	Placebo	Placebo comparator to empagliflozin
DRUG	Empagliflozin	Single-dose, 25 mg, two hours before clamp

Timeline

• Start date: 2022-06-22
• Primary completion: 2023-06-14
• Completion: 2023-06-14
• First posted: 2022-06-14
• Last updated: 2023-07-27

Locations

1 site across 1 country: Denmark