Effects of Diabetes Medications on Adrenal Function and Intestinal Microbiota

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: SGLT2 inhibitor; Drug: GLP-1 receptor agonist

• Registration Number: NCT04151849
• Lead Sponsor: University of Tartu

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.

Study Timeline

• Study First Submitted: 2019-10-29
• Study First Submitted QC: 2019-11-04
• Study First Posted: 2019-11-05
• Study Start: 2019-11-07
• Primary Completion: 2023-01-23
• Study Completion: 2023-01-23
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-19
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SGLT-2 inhibitor treatment	SGLT2 inhibitor	Patients starting treatment with any molecule belonging to the class of SGLT-2 inhibitors.
GLP-1 receptor agonist treatment	GLP-1 receptor agonist	Patients starting treatment with any molecule belonging to the class of GLP-1 receptor agonist.

Primary Outcome Measures

Name	Time	Method
Urinary aldosterone at 3 months	3 months	Overnight urinary aldosterone compared to pretreatment level.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Tartu University Hospital; 🇪🇪 Tartu, Estonia