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Clinical Trial Details

Trial ID: L5411
Source ID: NCT04151849
Associated Drug: Glp-1 Receptor Agonist
Title: Effects of Diabetes Medications on Adrenal Function and Intestinal Microbiota
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: GLP-1 receptor agonist|DRUG: SGLT2 inhibitor
Outcome Measures: Primary: Urinary aldosterone at 3 months, Overnight urinary aldosterone compared to pretreatment level., 3 months | Secondary: 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 | Other: 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, 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.
Sponsor/Collaborators: Sponsor: University of Tartu
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 23
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2019-11-07
Completion Date: 2023-01-23
Results First Posted:
Last Update Posted: 2023-02-21
Locations: Tartu University Hospital, Tartu, Estonia
URL: https://clinicaltrials.gov/show/NCT04151849