Effects of Diabetes Medications on Adrenal Function and Intestinal Microbiota

Type 2 Diabetes Clinical Trial

Official title:

Complementary Effects of New Diabetes Medications on Adrenal Function and Intestinal Microbiota

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04151849
• Other study ID #: 290/T-20
• Status: Completed
• Start date: November 7, 2019
• Est. completion date: January 23, 2023

Study information

• Verified date: February 2023
• Source: University of Tartu
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 23, 2023
• Est. primary completion date: January 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 2 Diabetes

Intervention

Drug:
• GLP-1 receptor agonist
Treatment with GLP-1 agonist for up to 1 year.
• SGLT2 inhibitor
Treatment with SGLT2 inhibitor for up to 1 year

Locations

Country	Name	City	State
Estonia	Tartu University Hospital	Tartu

Sponsors (1)

Lead Sponsor	Collaborator
University of Tartu

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum adrenocorticotropic hormone	Change in adrenocorticotropic hormone in serum compared to pretreatment level.	At 3 months and 12 months.
Other	Plasma cortisol	Change in plasma cortisol compared to pretreatment level	At 3 months and 12 months.
Other	Urinary cortisol	Change in overnight urinary cortisol compared to pretreatment level.	At 3 months and 12 months.
Other	Plasma aldosterone	Change in plasma aldosterone compared to pretreatment level.	At 3 months and 12 months.
Other	Plasma renin	Change in plasma renin compared to pretreatment level.	At 3 months and 12 months.
Other	Serum sodium	Change in serum sodium compared to pretreatment level.	At 3 months and 12 months.
Other	Serum potassium	Change in serum potassium compared to pretreatment level.	At 3 months and 12 months.
Other	Glycated hemoglobin A1c	Change in glycated hemoglobin A1c compared to pretreatment level.	At 3 months and 12 months.
Other	Ceruloplasmin	Change in plasma ceruloplasmin compared to pretreatment level.	At 3 months and 12 months.
Other	Ferritin	Change in plasma ferritin compared to pretreatment level.	At 3 months and 12 months.
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.
Secondary	Urinary aldosterone at 12 months	Overnight urinary aldosterone at 12 months compared to pretreatment level.	12 months