Clinical trial NCT04151849: Effects of Diabetes Medications on Adrenal Function and Intestinal Microbiota
Official title: Complementary Effects of New Diabetes Medications on Adrenal Function and Intestinal Microbiota
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: GLP-1 receptor agonist
SGLT-2 inhibitor
Lead sponsor: University of Tartu
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes who need treatment intensification with SGLT-2 inhibitor or GLP-1 receptor agonist.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Urinary aldosterone at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Change in gastrointestinal microbiota.
timeFrame: At 1 month after starting treatment, at 3 months and 12 months.
measure: Urinary aldosterone at 12 months
timeFrame: 12 months
Other outcomes:
measure: Serum adrenocorticotropic hormone
timeFrame: At 3 months and 12 months.
measure: Plasma cortisol
timeFrame: At 3 months and 12 months.
measure: Urinary cortisol
timeFrame: At 3 months and 12 months.
measure: Plasma aldosterone
timeFrame: At 3 months and 12 months.
measure: Plasma renin
timeFrame: At 3 months and 12 months.
measure: Serum sodium
timeFrame: At 3 months and 12 months.
measure: Serum potassium
timeFrame: At 3 months and 12 months.
measure: Glycated hemoglobin A1c
timeFrame: At 3 months and 12 months.
measure: Ceruloplasmin
timeFrame: At 3 months and 12 months.
measure: Ferritin
timeFrame: At 3 months and 12 months.
Locations:
city: Tartu
country: Estonia
facility: Tartu University Hospital
Study officials:
affiliation: University of Tartu, Institute of Biomedicine and Translational Medicine
name: Vallo Volke, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: