Effects of Diabetes Medications on Adrenal Function and Intestinal Microbiota

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-07

Study Completion Date

2023-01-23

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.

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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.

Conditions

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Type 2 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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GLP-1 receptor agonist treatment

Patients starting treatment with any molecule belonging to the class of GLP-1 receptor agonist.

GLP-1 receptor agonist

Intervention Type DRUG

Treatment with GLP-1 agonist for up to 1 year.

SGLT-2 inhibitor treatment

Patients starting treatment with any molecule belonging to the class of SGLT-2 inhibitors.

SGLT2 inhibitor

Intervention Type DRUG

Treatment with SGLT2 inhibitor for up to 1 year

Interventions

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GLP-1 receptor agonist

Treatment with GLP-1 agonist for up to 1 year.

Intervention Type DRUG

SGLT2 inhibitor

Treatment with SGLT2 inhibitor for up to 1 year

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No