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Completed

Effects of Diabetes Medications on Adrenal Function and Intestinal Microbiota

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

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

Enrollment

23

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

BMI ≥32HbA1c ≤10%

Primary endpoint

Urinary aldosterone

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04151849
Org study ID290/T-20

Timeline

Milestones

Study first posted2019-11-05actual
Study start2019-11-07actual
Primary completion2023-01-23actual
Study completion2023-01-23actual
Last update posted2023-02-21actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Patients with type 2 diabetes who need treatment intensification with SGLT-2 inhibitor or GLP-1 receptor agonist.

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.

Endpoints (13)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
11
Glycemic / diabetes
1
Safety / tolerability / PK
1

Glycemic / diabetes

1 endpoint
Other/protocol endpoint

Glycated hemoglobin A1c

Time frame:At 3 months and 12 months.

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Safety / tolerability / PK

1 endpoint
Other/protocol endpoint

Serum potassium

Time frame:At 3 months and 12 months.

change from baseline, descriptive

Other (unclassified)

11 endpoints
Primary/protocol endpoint/low confidence

Urinary aldosterone at 3 months

Time frame:3 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in gastrointestinal microbiota.

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

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Urinary aldosterone at 12 months

Time frame:12 months

change from baseline, improvement

Other/protocol endpoint/low confidence

Serum adrenocorticotropic hormone

Time frame:At 3 months and 12 months.

change from baseline, improvement

Other/protocol endpoint/low confidence

Plasma cortisol

Time frame:At 3 months and 12 months.

change from baseline, descriptive

Other/protocol endpoint/low confidence

Urinary cortisol

Time frame:At 3 months and 12 months.

change from baseline, descriptive

Other/protocol endpoint/low confidence

Plasma aldosterone

Time frame:At 3 months and 12 months.

change from baseline, descriptive

Other/protocol endpoint/low confidence

Plasma renin

Time frame:At 3 months and 12 months.

change from baseline, improvement

Other/protocol endpoint/low confidence

Serum sodium

Time frame:At 3 months and 12 months.

change from baseline, descriptive

Other/protocol endpoint/low confidence

Ceruloplasmin

Time frame:At 3 months and 12 months.

change from baseline, improvement

Other/protocol endpoint/low confidence

Ferritin

Time frame:At 3 months and 12 months.

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.