Orthostatic Intolerance After Bariatric Surgery
Açar sözlər
Mücərrəd
Tarixlər
| Son Doğrulandı: | 03/31/2020 |
| İlk təqdim: | 01/15/2019 |
| Təxmini qeydiyyat təqdim edildi: | 01/15/2019 |
| İlk Göndərmə: | 01/17/2019 |
| Son Yeniləmə Göndərildi: | 04/07/2020 |
| Son Yeniləmə Göndərildi: | 04/08/2020 |
| Həqiqi Təhsilin Başlama Tarixi: | 06/30/2018 |
| Təxmini İlkin Tamamlanma Tarixi: | 11/30/2020 |
| Təxmini İşin Tamamlanma Tarixi: | 11/30/2020 |
Vəziyyət və ya xəstəlik
Müdaxilə / müalicə
Drug: Atomoxetine
Drug: Placebo
Faza
Qol Qrupları
| Qol | Müdaxilə / müalicə |
|---|---|
| Experimental: Roux-en-Y gastric bypass (RYGB)/Atomoxetine Participants with standard of care RYGB will receive atomoxetine, 0.5 mg/kg/day for 3 days | |
| Experimental: Vertical sleeve gastrectomy (VSG) /Atomoxetine Participants with standard of care VSG will receive atomoxetine 0.5 mg/kg/day for 3 days | |
| Placebo Comparator: Roux-en-Y gastric bypass (RYGB)/Placebo Participants with standard of care RYGB will receive placebo 0.5 mg/kg/day for 3 days | |
| Placebo Comparator: Vertical sleeve gastrectomy (VSG)/ Placebo Participants with standard of care VSG will receive placebo 0.5 mg/kg/day for 3 days |
Uyğunluq Kriteriyaları
| Təhsil üçün uyğun yaşlar | 18 Years Üçün 18 Years |
| Təhsilə Uyğun Cinslər | All |
| Sağlam Könüllüləri qəbul edir | Bəli |
| Kriteriyalar | Inclusion Criteria: - Obese subjects that will undergo bariatric surgery or medical weight loss. - Age 18-60 years - BMI >35 kg/m2 - Weight < 400 lbs Exclusion Criteria: - Diabetes type 1 - Use of an alpha blockers, clonidine, beta-blockers. - Pregnancy or breast-feeding. Women of childbearing potential will be required to have undergone tubal ligation or to be using an oral contraceptive or barrier methods of birth control. - The use of any strong CYP2D6 inhibitor (e.g., fluoxetine, paroxetine, quinidine, tipranavir). - Use of selective NET inhibitors. - Use of monoamine oxidase inhibitors. - Cardiovascular disease such as myocardial infarction within six months prior to the study, presence of angina pectoris, significant arrhythmia, congestive heart failure (left ventricular hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy - History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack - Hematocrit < 34% - Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult - Mental conditions rendering a subject unable to understand the nature, scope and possible consequences of the study - Inability to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, unlikelihood of completing the study, and investigator discretion |
Nəticə
İlkin nəticə tədbirləri
1. Orthostatic Tolerance [about 1 hour]
İkincili Nəticə Tədbirləri
1. Norepinephrine transporter Inhibition [baseline and 30 minutes]
