Type 2 Diabetes
Conditions
Keywords
GLP-1 receptor agonist, SGLT-2 inhibitor
Brief 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.
Interventions
DRUGGLP-1 receptor agonist
Treatment with GLP-1 agonist for up to 1 year.
DRUGSGLT2 inhibitor
Treatment with SGLT2 inhibitor for up to 1 year
Sponsors
University of Tartu
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary aldosterone at 3 months | 3 months | Overnight urinary aldosterone compared to pretreatment level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in gastrointestinal microbiota. | At 1 month after starting treatment, at 3 months and 12 months. | Fecal microbiota will be compared to pre-treatment sample. |
| Urinary aldosterone at 12 months | 12 months | Overnight urinary aldosterone at 12 months compared to pretreatment level. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Plasma aldosterone | At 3 months and 12 months. | Change in plasma aldosterone compared to pretreatment level. |
| Plasma renin | At 3 months and 12 months. | Change in plasma renin compared to pretreatment level. |
| Serum sodium | At 3 months and 12 months. | Change in serum sodium compared to pretreatment level. |
| Serum adrenocorticotropic hormone | At 3 months and 12 months. | Change in adrenocorticotropic hormone in serum compared to pretreatment level. |
| Glycated hemoglobin A1c | At 3 months and 12 months. | Change in glycated hemoglobin A1c compared to pretreatment level. |
| Ceruloplasmin | At 3 months and 12 months. | Change in plasma ceruloplasmin compared to pretreatment level. |
| Ferritin | At 3 months and 12 months. | Change in plasma ferritin compared to pretreatment level. |
| Serum potassium | At 3 months and 12 months. | Change in serum potassium compared to pretreatment level. |
| Plasma cortisol | At 3 months and 12 months. | Change in plasma cortisol compared to pretreatment level |
| Urinary cortisol | At 3 months and 12 months. | Change in overnight urinary cortisol compared to pretreatment level. |
Countries
Estonia
Outcome results
None listed