Effect of Serum LDL Cholesterol Concentration on Pancreatic Insulin Secretion

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Dyslipidemia is characterized by low levels of HDLs, hypertriglyceridemia as well as an increases proportion of small dense LDLs. Changes in lipoprotein particles and its concentrations, especially increased levels of pro-atherogenic LDL particles play an important role in the development of cardiovascular diseases. It is well established that statin/PCSK9-inhibitor treatment is very effective in lowering LDL cholesterol levels and therefore in preventing cardiovascular events. Besides the beneficial effects on cardiovascular system, these therapies are unfortunately linked to increased risk for type 2 diabetes. However underlying mechanisms for the association between LDL cholesterol levels and the risk for type 2 diabetes remains largely unknown.Type 2 diabetes is especially characterized by insulin resistance and impaired insulin secretion from pancreatic beta-cells. Insulin resistance alone is insufficient to cause type 2 diabetes, as long as the ß-cell is able to compensate for the increased demand for insulin. Once this compensatory mechanism reaches its physiological limits, individuals progress to type 2 diabetes. Accordingly we aimed to investigate the associations between LDL cholesterol concentrations and the key issue in the pathogenesis of type 2 diabetes, insulin secretion before and after lowering cholesterol concentration by treatment with Evolocumab for 12 weeks in patients with medical indication for a treatment with a PCSK9-inhibitor. Therefore, patients will either undergo a hyperglycemic clamp or a oral glucose tolerance test in randomized manner.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: No
View:

• Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures

• Medical indication for the treatment with a PCSK9-inhibitor

• HbA1c < 6,5%

Locations
Other Locations
Germany
University of Tuebingen, Department of Internal Medicine IV
Recruiting
Tuebingen
Contact Information
Primary
Andreas Fritsche, Prof.
andreas.fritsche@med.uni-tuebingen.de
0049 (0)7071-29 80590
Time Frame
Start Date: July 28, 2020
Estimated Completion Date: June 15, 2023
Participants
Target number of participants: 40
Treatments
Experimental: LDL lowering therapy
Patients will receive the PCSK9-inhibitor Evolocumab as part of routine clinical management within the indication of this drug.
Sponsors
Leads: University Hospital Tuebingen

This content was sourced from clinicaltrials.gov

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