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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLP-1 receptor agonist treatment | Patients starting treatment with any molecule belonging to the class of GLP-1 receptor agonist. |
| |
| SGLT-2 inhibitor treatment | Patients starting treatment with any molecule belonging to the class of SGLT-2 inhibitors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLP-1 receptor agonist | Drug | Treatment with GLP-1 agonist for up to 1 year. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urinary aldosterone at 3 months | Overnight urinary aldosterone compared to pretreatment level. | 3 months |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum adrenocorticotropic hormone | Change in adrenocorticotropic hormone in serum compared to pretreatment level. | At 3 months and 12 months. |
| Plasma cortisol | Change in plasma cortisol compared to pretreatment level |
Inclusion Criteria:
Exclusion Criteria:
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Patients with type 2 diabetes who need treatment intensification with SGLT-2 inhibitor or GLP-1 receptor agonist.
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| Name | Affiliation | Role |
|---|---|---|
| Vallo Volke, MD, PhD | University of Tartu, Institute of Biomedicine and Translational Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tartu University Hospital | Tartu | Estonia |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077203 | Sodium-Glucose Transporter 2 Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
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| SGLT2 inhibitor | Drug | Treatment with SGLT2 inhibitor for up to 1 year |
|
Overnight urinary aldosterone at 12 months compared to pretreatment level.
| 12 months |
| At 3 months and 12 months. |
| Urinary cortisol | Change in overnight urinary cortisol compared to pretreatment level. | At 3 months and 12 months. |
| Plasma aldosterone | Change in plasma aldosterone compared to pretreatment level. | At 3 months and 12 months. |
| Plasma renin | Change in plasma renin compared to pretreatment level. | At 3 months and 12 months. |
| Serum sodium | Change in serum sodium compared to pretreatment level. | At 3 months and 12 months. |
| Serum potassium | Change in serum potassium compared to pretreatment level. | At 3 months and 12 months. |
| Glycated hemoglobin A1c | Change in glycated hemoglobin A1c compared to pretreatment level. | At 3 months and 12 months. |
| Ceruloplasmin | Change in plasma ceruloplasmin compared to pretreatment level. | At 3 months and 12 months. |
| Ferritin | Change in plasma ferritin compared to pretreatment level. | At 3 months and 12 months. |
| D004700 | Endocrine System Diseases |
| D045505 | Physiological Effects of Drugs |