Orthostatic Intolerance After Bariatric Surgery
Raktažodžiai
Santrauka
Datos
| Paskutinį kartą patikrinta: | 03/31/2020 |
| Pirmasis pateikimas: | 01/15/2019 |
| Numatytas registravimas pateiktas: | 01/15/2019 |
| Pirmas paskelbtas: | 01/17/2019 |
| Paskutinis atnaujinimas pateiktas: | 04/07/2020 |
| Paskutinis atnaujinimas paskelbtas: | 04/08/2020 |
| Faktinė studijų pradžios data: | 06/30/2018 |
| Numatoma pirminio užbaigimo data: | 11/30/2020 |
| Numatoma studijų užbaigimo data: | 11/30/2020 |
Būklė ar liga
Intervencija / gydymas
Drug: Atomoxetine
Drug: Placebo
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| 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 |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | 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 |
Rezultatas
Pirminės rezultatų priemonės
1. Orthostatic Tolerance [about 1 hour]
Antrinės rezultatų priemonės
1. Norepinephrine transporter Inhibition [baseline and 30 minutes]
