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Effects of Diabetes Medications on Adrenal Function and Intestinal Microbiota

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ClinicalTrials.gov Identifier: NCT04151849
Recruitment Status : Recruiting
First Posted : November 5, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Vallo Volke, University of Tartu

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.

Condition or disease Intervention/treatment
Type 2 Diabetes Drug: GLP-1 receptor agonist Drug: SGLT2 inhibitor

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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Complementary Effects of New Diabetes Medications on Adrenal Function and Intestinal Microbiota
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Treatment with GLP-1 agonist for up to 1 year.

SGLT-2 inhibitor treatment
Patients starting treatment with any molecule belonging to the class of SGLT-2 inhibitors.
Drug: SGLT2 inhibitor
Treatment with SGLT2 inhibitor for up to 1 year




Primary Outcome Measures :
  1. Urinary aldosterone at 3 months [ Time Frame: 3 months ]
    Overnight urinary aldosterone compared to pretreatment level.


Secondary Outcome Measures :
  1. Change in gastrointestinal microbiota. [ Time Frame: At 1 month after starting treatment, at 3 months and 12 months. ]
    Fecal microbiota will be compared to pre-treatment sample.

  2. Urinary aldosterone at 12 months [ Time Frame: 12 months ]
    Overnight urinary aldosterone at 12 months compared to pretreatment level.


Other Outcome Measures:
  1. Serum adrenocorticotropic hormone [ Time Frame: At 3 months and 12 months. ]
    Change in adrenocorticotropic hormone in serum compared to pretreatment level.

  2. Plasma cortisol [ Time Frame: At 3 months and 12 months. ]
    Change in plasma cortisol compared to pretreatment level

  3. Urinary cortisol [ Time Frame: At 3 months and 12 months. ]
    Change in overnight urinary cortisol compared to pretreatment level.

  4. Plasma aldosterone [ Time Frame: At 3 months and 12 months. ]
    Change in plasma aldosterone compared to pretreatment level.

  5. Plasma renin [ Time Frame: At 3 months and 12 months. ]
    Change in plasma renin compared to pretreatment level.

  6. Serum sodium [ Time Frame: At 3 months and 12 months. ]
    Change in serum sodium compared to pretreatment level.

  7. Serum potassium [ Time Frame: At 3 months and 12 months. ]
    Change in serum potassium compared to pretreatment level.

  8. Glycated hemoglobin A1c [ Time Frame: At 3 months and 12 months. ]
    Change in glycated hemoglobin A1c compared to pretreatment level.

  9. Ceruloplasmin [ Time Frame: At 3 months and 12 months. ]
    Change in plasma ceruloplasmin compared to pretreatment level.

  10. Ferritin [ Time Frame: At 3 months and 12 months. ]
    Change in plasma ferritin compared to pretreatment level.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04151849


Contacts
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Contact: Vallo Volke, MD, PhD +37256489216 vallo.volke@ut.ee

Locations
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Estonia
Tartu University Hospital Recruiting
Tartu, Estonia
Contact: Vallo Volke, PhD         
Contact: Ingrid Reppo         
Sponsors and Collaborators
University of Tartu
Investigators
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Principal Investigator: Vallo Volke, MD, PhD University of Tartu, Institute of Biomedicine and Translational Medicine

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Responsible Party: Vallo Volke, Professor, University of Tartu
ClinicalTrials.gov Identifier: NCT04151849     History of Changes
Other Study ID Numbers: 290/T-20
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Vallo Volke, University of Tartu:
GLP-1 receptor agonist
SGLT-2 inhibitor
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sodium-Glucose Transporter 2 Inhibitors
Glucagon
Glucagon-Like Peptide 1
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents