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| Name | Class |
|---|---|
| Actelion | INDUSTRY |
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The purpose of this study is to establish the effect of ET blockade on vascular adaptations during an 8-week exercise program in subjects with T2DM. We hypothesize that combining ET - blockade with exercise training leads to an acute increase of exercise induced blood flow when compared with exercise alone. We expect that this will lead to an optimization of vascular training effect in T2DM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bosentan + Exercise | Experimental | 2x/day 62.5 mg Bosentan for 4 weeks alongside 3x/week supervised exercise 2x/day 125 mg Bosentan for 4 weeks alongside 3x/week supervised exercise |
|
| Placebo + Exercise | Placebo Comparator | 2x/day 62.5 mg Placebo for 4 weeks alongside 3x/week supervised exercise 2x/day 125 mg Placebo for 4 weeks alongside 3x/week supervised exercise |
|
| Exercise | Other | 3x/week supervised exercise for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bosentan | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Flow mediated dilation | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Conduit Artery Dilator Capacity | 8 weeks | |
| Intima-Media Thickness | 8 weeks | |
| Maximal Oxygen Uptake |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Nijmegen Medical Centre | Nijmegen | Gelderland | 6525 EX | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25172889 | Derived | Schreuder TH, Duncker DJ, Hopman MT, Thijssen DH. Randomized controlled trial using bosentan to enhance the impact of exercise training in subjects with type 2 diabetes mellitus. Exp Physiol. 2014 Nov;99(11):1538-47. doi: 10.1113/expphysiol.2014.081182. Epub 2014 Aug 28. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077300 | Bosentan |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Placebo |
| Drug |
|
|
| Exercise | Behavioral | Supervised exercise training program of 8 weeks, for 3x/week |
|
|
| 8 weeks |
| D004700 | Endocrine System Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |