Effects of Diabetes Medications on Adrenal Function and Intestinal Microbiota

NCT04151849 | Completed

• 1 other identifier: 290/T-20
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

GLP-1 receptor agonist; SGLT-2 inhibitor

Outcome Measures

Primary Outcomes (1)

• Urinary aldosterone at 3 months

  Overnight urinary aldosterone compared to pretreatment level.

  3 months

Secondary Outcomes (2)

• Change in gastrointestinal microbiota.

  At 1 month after starting treatment, at 3 months and 12 months.

• Urinary aldosterone at 12 months

  12 months

Other Outcomes (10)

• Serum adrenocorticotropic hormone

  At 3 months and 12 months.

• Plasma cortisol

  At 3 months and 12 months.

• Urinary cortisol

  At 3 months and 12 months.

Study Arms (2)

GLP-1 receptor agonist treatment

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

Drug: GLP-1 receptor agonist

SGLT-2 inhibitor treatment

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

Drug: SGLT2 inhibitor

Interventions

GLP-1 receptor agonist DRUG

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

GLP-1 receptor agonist treatment

SGLT2 inhibitor DRUG

Treatment with SGLT2 inhibitor for up to 1 year

SGLT-2 inhibitor treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Tartu: lead

Study Sites (1)

Tartu University Hospital

Tartu, Estonia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Officials

• Vallo Volke, MD, PhD

  University of Tartu, Institute of Biomedicine and Translational Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 5, 2019
• Study Start: November 7, 2019
• Primary Completion: January 23, 2023
• Study Completion: January 23, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)