NCT04151849

Effects of Diabetes Medications on Adrenal Function and Intestinal Microbiota

Complementary Effects of New Diabetes Medications on Adrenal Function and Intestinal Microbiota

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 23 (actual)
• Sponsor: University of Tartu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary aim of this observational study is to describe the effects of glucagon-like peptide-1 (GLP-1) receptor agonists and Sodium-Glucose Co-transporter 2 inhibitors ( SGLT-2 inhibitors) on adrenal function. Secondary endpoint is change in intestinal microbiota.

Detailed description

This is an observational study conducted in patients with type 2 diabetes starting treatment with either GLP-1 receptor agonist or sodium-glucose cotransporter-2 (SGLT-2) inhibitor. Planned study cohort consists of 60 patients: 30 patients starting GLP-1 receptor agonist treatment and 30 patients starting SGLT-2 inhibitor treatment. All patients must have metformin as background therapy. All other diabetes medications are allowed. Patients are tested before starting treatment, at 1 month (stool sample only), 3 months and 12 months after starting treatment. The primary endpoint is change in overnight urinary aldosterone corrected for creatinine. Secondary endpoint is change in intestinal microbiota composition.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	GLP-1 receptor agonist	Treatment with GLP-1 agonist for up to 1 year.
DRUG	SGLT2 inhibitor	Treatment with SGLT2 inhibitor for up to 1 year

Timeline

• Start date: 2019-11-07
• Primary completion: 2023-01-23
• Completion: 2023-01-23
• First posted: 2019-11-05
• Last updated: 2023-02-21

Locations

1 site across 1 country: Estonia