Effects of Diabetes Medications on Adrenal Function and Intestinal Microbiota

University of Tartu

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Drug: SGLT2 inhibitor; Drug: GLP-1 receptor agonist

Study type: Observational

Funder types: Other

Identifiers

NCT04151849

290/T-20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years
• Type 2 diabetes
• HbA1c < 10%
• BMI >32
• Daily dose of metformin 1,5 g or more.
• No change in diabetes treatment at least 90 days before starting the study.
• Never used SGLT-2 inhibitors or/and GLP-1 receptor agonist.
• Tested negative to glutamic acid decarboxylase 65 autoantibodies.

Exclusion criteria

• Pregnancy and lactation.
• Use of systemic antibiotic treatment < 60 days before starting the study.
• Use of spironolactone < 60 days before starting the study.
• Use of oral contraceptives or hormonal replacement therapy.
• Use of immunosuppressive drug
• Heart failure New York Heart Association III-IV
• Severe liver disease.
• Malignant disease.

Trial design

23 participants in 2 patient groups

GLP-1 receptor agonist treatment

Description:

Patients starting treatment with any molecule belonging to the class of GLP-1 receptor agonist.

Treatment:

Drug: GLP-1 receptor agonist

SGLT-2 inhibitor treatment

Description:

Patients starting treatment with any molecule belonging to the class of SGLT-2 inhibitors.

Treatment:

Drug: SGLT2 inhibitor