AzTrials
AzTrials

Diabetes Mellitus, Type 2EmpaNCT03131232

The Effect of Empagliflozin on Glucose Metabolism, Weight, Blood Pressure and Cardiac Function (NT-proBNP) Should be Investigated

An observational study of Diabetes Mellitus, Type 2, run by RWTH Aachen University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

In summary, the registry should provide novel insight into potential mechanisms of cardiovascular risk reduction in patients treated with Empagliflozin with an indication of intensified glucose lowering therapy based on their HbA1c level. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
How many people
46 participants
Where
No sites listed yet
Study dates
10 Dec 2015to 31 Dec 2017
How long will I take part?
6 Months
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: If possible, all patients of the Department MK1 Uniklinik Aachen who are treated with empagliflozine

Who may be able to join

  • Diabetes mellitus II Patients with whom an empagliflozine treatment is to be initiated from a clinical indication

Who cannot join

  • Inability to consent to the study

About this study

Official title: The Aim of This Study is to Investigate the Protective Effect of Empagliflozin on the Cardiovascular System in Diabetes Mellitus Patients

In summary, the registry should provide novel insight into potential mechanisms of cardiovascular risk reduction in patients treated with Empagliflozin with an indication of intensified glucose lowering therapy based on their HbA1c level.

Read the detailed description

Patients with diabetes exhibit an increased risk for the development of cardiovascular disease with a significantly impaired prognosis compared to patients without diabetes. Recent data from the EMPA-REG Outcome Trial suggest that treatment with the SGLT-2 inhibitor Empagliflozin reduces cardiovascular events, cardiovascular mortality as well as hospitalization for heart failure in patients with type 2 diabetes and pre-existing cardiovascular disease. Empagliflozin leads to reduction of blood glucose by an increased glucose excretion reduces blood pressure and weight. Still, it remains unclear how empagliflozin led to this pronounced reduction of cardiovascular mortality the EMPA-REG OUTCOME trial. Thus, our registry will analyse various biochemical as well as clinical markers in patients with type 2 diabetes and newly initiated treatment with empagliflozin. and an indication for intensification of glucose lowering therapy with empagliflozin. Patients with an indication for an intensified glucose-lowering therapy (HbA1c > 7,5%) will receive 10 mg empagliflozin and we will perform biochemical analyses of blood samples including insulin, glucagon as well as metabolites at baseline as well as after 1 and 6 months. In addition we will assess echocardiographical data.

Medical subject headings
Diabetes Mellitus, Type 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The effect of empagliflozine on glucose metabolism

    HbA1c in %

    Measured: 6 month

  2. The effect of empagliflozine on glucose metabolism

    Body weight in kg

    Measured: 6 month

  3. The effect of empagliflozine on glucose metabolism

    BMI in kg/m²

    Measured: 6 month

  4. The effect of empagliflozine on glucose metabolism

    blood pressure in mmHg

    Measured: 6 month

  5. The effect of empagliflozine on glucose metabolism

    NT-pro BNP in pg/ml

    Measured: 6 month

Secondary outcomes (4)

  1. Frequency of urinary and urogenital infections

    Urinary infection as reported by the patient CRP (Creactive protein) in mg/dl

    Measured: 6 month

  2. detection differential regulation of endogenous and exogenous metabolites in addition to circulating proteins by empagliflozin.

    perform metabolomic and proteomic profiling of serum samples

    Measured: 6 month

  3. Lipid measurements

    LDL-C in mg/dl HDL-C in mg/dl TG (triglyceride) in mg/dl

    Measured: 6 month

  4. - echocardiographic parameters (if collected) with determination of the systolic and diastolic left ventricular function

    LV-EF (left ventricular ejection fraction) in % LV (left ventricular) global strain

    Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2017
  2. Study start10 Dec 2015
  3. Primary completion1 Aug 2017 (estimated)
  4. Study completion31 Dec 2017 (estimated)

Resources

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
46 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03131232
Sponsor's protocol ID
15-152
Acronym
Empa
Status last verified
Apr 2017
First submitted
13 Apr 2017
Last updated
27 Apr 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by RWTH Aachen University.

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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

The effect of empagliflozine on glucose metabolism (time frame: 6 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03131232.

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 27 Apr 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in