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Influence of DPP-4 on Inflammatory Parameters in Diabetics: Gender Aspects

NCT01162772 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2010-07-16

No results posted yet for this study

Summary

Cardiovascular events are the most common cause for death in type 2 diabetes mellitus (T2DM) patients. Male diabetics have a 2 to 3 fold risk for cardiovascular disease (CVD) whereas female diabetes patients have a 3 to 7 fold risk for suffering from a CVD.

Endothelial dysfunction (ED) plays a central role in the development of atherosclerotic lesions. Moreover, ED represents an important diagnostic and prognostic parameter to estimate the cardiovascular risk in an early state. Experimental and clinical studies indicate that T2DM is closely associated with ED, which may be the consequence of a reduced bioactivity of nitric oxide (NO).

The success of diabetes therapy is monitored by the long-term parameter HbA1c. However, only two thirds of all patients with T2DM in the USA and Europe find themselves in the recommended HbA1c span (6.5-7.0 %). Consequently, oral anti-diabetic medication needs permanent adjustment and intensification in order to delaying the progress of T2DM.

Recently, two peptide hormones with insulinotropic effects were identified. These hormones, glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are secreted by the gastrointestinal tract after exposure to glucose in nutrition. Physiological effects are increased insulin secretion, inhibition of glucagon secretion and reduction of body weight. Furthermore, these incretins are reduced in patients with impaired glucose tolerance. Thus, the therapeutic approach lies within the elevation of GLP-1 and GIP by preventing their degradation through the enzyme DPP-4 (dipeptidylpeptidase 4).

Thereby, the so-called gliptins inhibit the DPP-4 enzymes. Best results in HbA1c reduction were achieved when gliptins were combined with metformin, glimepiride or pioglitazone.

In this study, patients with T2DM, who are taking metformin as first line medication but do not achieve a HbA1c below 7.0 %, will routinely get an add-on therapy with gliptins (Vildagliptin or Sitagliptin) as second line therapy according to the guidelines of the Österreichische Diabetes Gesellschaft (ÖDG) prescribed by a medical doctor not involved in this study. This medication is a ÖDG standard therapy in T2DM, which patients receive anyway despite this study. Therefore, the therapy with gliptins is not a study medication and is not influenced by the study either. Only patients, who will meet the inclusion criteria of the study and voluntarily participate in the study, will be investigated.

Conditions

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Jeanette Strametz-Juranek, MD · MUV, Department of Internal Medicine II, Division of Cardiology

  • Alexandra Kautzky-Willer, MD · MUV, Department of Medicine III, Division of Endocrinology

Eligibility

Min Age
25 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-10-31

Countries

  • Austria

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01162772 on ClinicalTrials.gov