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financial support withdrawn
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| Name | Class |
|---|---|
| Institut für Gesundheits- und Praxismanagement GmbH | UNKNOWN |
In patients with impaired glucose tolerance (IGT), the researchers want to study the relative effects of pioglitazone, simvastatin, or the combination of both on:
We want to study the relative effects of pioglitazone, simvastatin or the combination of both on intima media thickness (IMT), heart rate variability (HRV), flow-mediated vasodilatation (FMD) of the brachial artery and vascular/metabolic lab parameters in patients with impaired glucose tolerance (IGT). Previous studies have shown a reduction in IMT for both pioglitazone and simvastatin in type 2 diabetics. Many patients with diabetes mellitus develop diabetic polyneuropathy which can be assessed by measuring HRV. It has been shown that pioglitazone has a positive effect on HRV in type 2 diabetics. Questions remain on the relative efficacy of pioglitazone and simvastatin on the parameters mentioned above. Also, there is only scarce data in patients with IGT (as opposed to overt diabetes mellitus). There are no data on the relative effects of pioglitazone and simvastatin on flow-mediated vasodilatation (FMD) of the brachial artery as a surrogate marker for endothelial function.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pioglitazone | Drug | |||
| simvastatin | Drug | |||
| pioglitazone + simvastatin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change in intima media thickness of carotid artery |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability | ||
| Flow-mediated dilatation of brachial artery | ||
| Vascular/metabolic lab parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerhard Schuler, MD | University of Leipzig | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Praxis Antje Horn | Gera | 07548 | Germany | |||
| Praxis Gunter Kässner |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33210751 | Derived | Ipsen EO, Madsen KS, Chi Y, Pedersen-Bjergaard U, Richter B, Metzendorf MI, Hemmingsen B. Pioglitazone for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 19;11(11):CD013516. doi: 10.1002/14651858.CD013516.pub2. |
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| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006943 | Hyperglycemia |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Leipzig |
| 04229 |
| Germany |
| Praxis Heidrun Täschner | Leipzig | 04249 | Germany |
| Praxis Martin Schönauer | Leipzig | 04275 | Germany |
| University of Leipzig Heart Center | Leipzig | 04289 | Germany |
| Praxis Matthias Weissbrodt | Leipzig | 04299 | Germany |
| Praxis Matthias Schreiner | Leipzig | 04357 | Germany |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |