Type 2 DiabetesNCT04151849
Effects of Diabetes Medications on Adrenal Function and Intestinal Microbiota
An observational study of Type 2 Diabetes, run by University of Tartu at 1 site in Estonia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- GLP-1 receptor agonist and SGLT2 inhibitor
- How many people
- 23 participants
- Where
- 1 siteEstonia
- Study dates
- 7 Nov 2019to 23 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with type 2 diabetes who need treatment intensification with SGLT-2 inhibitor or GLP-1 receptor agonist.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Complementary Effects of New Diabetes Medications on Adrenal Function and Intestinal Microbiota
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- GLP-1 receptor agonist, SGLT2 inhibitor
- Keywords
- GLP-1 receptor agonist, SGLT-2 inhibitor
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1 receptor agonistDrug
Treatment with GLP-1 agonist for up to 1 year.
SGLT2 inhibitorDrug
Treatment with SGLT2 inhibitor for up to 1 year
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 receptor agonist treatment | Patients starting treatment with any molecule belonging to the class of GLP-1 receptor agonist. Receives: Drug: GLP-1 receptor agonist | |
| SGLT-2 inhibitor treatment | Patients starting treatment with any molecule belonging to the class of SGLT-2 inhibitors. Receives: Drug: SGLT2 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary aldosterone at 3 months
Overnight urinary aldosterone compared to pretreatment level.
Measured: 3 months
Secondary outcomes (2)
Change in gastrointestinal microbiota.
Fecal microbiota will be compared to pre-treatment sample.
Measured: At 1 month after starting treatment, at 3 months and 12 months.
Urinary aldosterone at 12 months
Overnight urinary aldosterone at 12 months compared to pretreatment level.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start7 Nov 2019
- Primary completion23 Jan 2023
- Study completion23 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vallo Volke, University of Tartu
- Investigators
- Vallo Volke, MD, PhD, Principal investigator, University of Tartu, Institute of Biomedicine and Translational Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151849
- Sponsor's protocol ID
- 290/T-20
- Status last verified
- Feb 2023
- First submitted
- 29 Oct 2019
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complementary Effects of New Diabetes Medications on Adrenal Function and Intestinal Microbiota
- ClinicalTrials.gov ID
- NCT04151849
- Acronym / sponsor ID
- 290/T-20
- Conditions
- Type 2 Diabetes
- Keywords
- GLP-1 receptor agonist, SGLT-2 inhibitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 23 Jan 2023 (actual)
- Study completion
- 23 Jan 2023 (actual)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLP-1 receptor agonist treatment | – | Drug: GLP-1 receptor agonistPatients starting treatment with any molecule belonging to the class of GLP-1 receptor agonist. |
| SGLT-2 inhibitor treatment | – | Drug: SGLT2 inhibitorPatients starting treatment with any molecule belonging to the class of SGLT-2 inhibitors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 diabetes who need treatment intensification with SGLT-2 inhibitor or GLP-1 receptor agonist.
Key inclusion criteria (8 listed)
- Age > 18 years
- Type 2 diabetes
- HbA1c < 10%
- BMI >32
- Daily dose of metformin 1,5 g or more.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLP-1 receptor agonistTreatment with GLP-1 agonist for up to 1 year. | Drug | GLP-1 receptor agonist treatment |
| SGLT2 inhibitorTreatment with SGLT2 inhibitor for up to 1 year | Drug | SGLT-2 inhibitor treatment |
Primary outcome
Urinary aldosterone at 3 months
Time frame: 3 months
Overnight urinary aldosterone compared to pretreatment level.
2 secondary outcomes
Change in gastrointestinal microbiota.
Time frame: At 1 month after starting treatment, at 3 months and 12 months.
Urinary aldosterone at 12 months
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vallo Volke, MD, PhD principal investigator
University of Tartu, Institute of Biomedicine and Translational Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by University of Tartu at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary aldosterone at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.