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DIATOR-Diabetes Intervention With Atorvastatin

2014-08-27 03:19:25 | BioPortfolio

Summary

Clinical studies have shown that immunomodulators (like Anti-CD3 antibodies) have effects on beta-cell-preservation. The lipid-lowering agent atorvastatin is also a potent immunomodulator. In this study the effects of 80 mg atorvastatin per day on preservation of beta-cell function in recent onset type 1 diabetes were studied, as determined by stimulated C-peptide levels.

Description

The objectives of this study were as follows:

- To assess the effect of atorvastatin on pancreatic beta-cell function as measured by C-peptide after a liquid mixed meal stimulation in patients with newly diagnosed type 1 diabetes,

- To assess the effect on metabolic control as measured by HbA1c and insulin requirements,

- To assess safety and tolerability of atorvastatin in subjects with newly diagnosed type 1 diabetes,

- To assess the effect on risk factors of diabetic complications as indicated by changes in lipids and CRP, and

- To assess the effect on systemic immune abnormalities as measured by effects on beta-cell autoantibodies, blood cytokines and chemokines on protein and transcriptional level.

Study duration: 18 months

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Type 1 Diabetes

Intervention

Atorvastatin, atorvastatin matching placebo

Location

Diabetes-Zentrum Mergentheim
Bad Mergentheim
Germany
97980

Status

Terminated

Source

Profil Institut für Stoffwechselforschung GmbH

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:25-0400

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A pyrrole and heptanoic acid derivative,HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITOR (statin), and ANTICHOLESTEREMIC AGENT that is used to reduce serum levels of LDL-CHOLESTEROL; APOLIPOPROTEIN B; AND TRIGLYCERIDES and to increase serum levels of HDL-CHOLESTEROL in the treatment of HYPERLIPIDEMIAS and prevention of CARDIOVASCULAR DISEASES in patients with multiple risk factors.

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Urination of a large volume of urine with an increase in urinary frequency, commonly seen in diabetes (DIABETES MELLITUS; DIABETES INSIPIDUS).

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