Effects of Diabetes Medications on Adrenal Function and Intestinal Microbiota

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: GLP-1 receptor agonist
* Drug: SGLT2 inhibitor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GLP-1 receptor agonist treatment<br>Patients starting treatment with any molecule belonging to the class of GLP-1 receptor agonist. | Drug: GLP-1 receptor agonist<br>* Treatment with GLP-1 agonist for up to 1 year.<br>|
| SGLT-2 inhibitor treatment<br>Patients starting treatment with any molecule belonging to the class of SGLT-2 inhibitors. | Drug: SGLT2 inhibitor<br>* Treatment with SGLT2 inhibitor for up to 1 year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary aldosterone at 3 months | Overnight urinary aldosterone compared to pretreatment level. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in gastrointestinal microbiota. | Fecal microbiota will be compared to pre-treatment sample. | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GLP-1 receptor agonist, SGLT-2 inhibitor