Effects of Diabetes Medications on Adrenal Function and Intestinal Microbiota

University of Tartu23 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Type 2 Diabetes

Interventions

GLP-1 receptor agonistDRUG

Treatment with GLP-1 agonist for up to 1 year.

SGLT2 inhibitorDRUG

Treatment with SGLT2 inhibitor for up to 1 year

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tartu University Hospital

Tartu, Estonia

Outcomes

Primary Outcomes

Urinary aldosterone at 3 months

Overnight urinary aldosterone compared to pretreatment level.

Time frame: 3 months

Secondary Outcomes

Change in gastrointestinal microbiota.

Fecal microbiota will be compared to pre-treatment sample.

Time frame: At 1 month after starting treatment, at 3 months and 12 months.

Urinary aldosterone at 12 months

Overnight urinary aldosterone at 12 months compared to pretreatment level.

Time frame: 12 months

Data from ClinicalTrials.gov

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