Inflammation Reduction by TREhalose AdminisTration
Ключевые слова
абстрактный
Даты
| Последняя проверка: | 01/31/2020 |
| Первый отправленный: | 10/02/2018 |
| Предполагаемая регистрация отправлена: | 10/04/2018 |
| Первое сообщение: | 10/08/2018 |
| Последнее обновление отправлено: | 02/17/2020 |
| Последнее обновление опубликовано: | 02/18/2020 |
| Фактическая дата начала исследования: | 07/06/2019 |
| Предполагаемая дата завершения начальной школы: | 05/31/2020 |
| Предполагаемая дата завершения исследования: | 07/31/2020 |
Состояние или болезнь
Вмешательство / лечение
Drug: Trehalose
Drug: Placebo
Фаза
Группы рук
| Рука | Вмешательство / лечение |
|---|---|
| Experimental: Trehalose Participants will be received intravenous trehalose infusion weekly (15 g/week) for a period of 12 weeks | Drug: Trehalose Trehalose is a natural disaccharide sugar found extensively among miscellaneous organisms including bacteria, plants, insects, yeast, fungi, and invertebrates. By preventing protein denaturation, it plays various protective roles against stress conditions such as heat, freeze, oxidation, desiccation and dehydration. Owing to this capacity, trehalose is an FDA-approved pharmaceutical excipient that is used as a stabilizer in numerous medicines including parenteral products.
In this study, all injections will be conducted by a trained nurse in the presence of a specialist physician at a duration of 45-90 minutes. |
| Placebo Comparator: Placebo Participants will be received equal volume of normal saline weekly for a period of 12 weeks | Drug: Placebo A solution of 0.90% w/v of sodium chloride (NaCl) in water |
Критерии приемлемости
| Возраст, имеющий право на обучение | 18 Years Чтобы 18 Years |
| Полы, имеющие право на обучение | All |
| Принимает здоровых добровольцев | да |
| Критерии | Inclusion Criteria: - Men and women aged between 18-55 years - Having a history of acute coronary syndrome - Having a baseline high-sensitivity C-reactive protein (hs-CRP) of ≥ 2mg/L - Willingness to participate in the trials. Exclusion Criteria: - Lactation or breastfeeding - Diabetes mellitus - Nephrotic syndrome or Estimated Glomerular Filtration Rate (eGFR) < 30/mL/min/1.73m2 - Active or recurrent hepatic disease or/and alanine aminotransferase (ALT)/aspartate aminotransferase (AST) (ALT/AST) of > 3 times upper normal limit or total bilirubin of > 2 times upper normal limit - Active infectious or febrile disease - Any type of malignancy - History of transplantation - Consumption of immunosuppressive drugs. |
Результат
Основные показатели результатов
1. Arterial wall inflammation in the aorta and carotid arteries [At the beginning and end of the intervention trial (Day 0 and week 12)]
Меры вторичного результата
1. Carotid intima-media thickness (cIMT) [At the beginning and end of the intervention trial (Day 0 and week 12)]
2. Measuring beclin-1 to assess autophagy activation [At the beginning and end of the intervention trial (Day 0 and week 12)]
3. Measuring high-sensitivity C-reactive protein (hs-CRP) to assess systemic inflammation [At the beginning and end of the intervention trial (Day 0 and week 12)]
4. Measuring complete blood count (CBC) (Safety) [At the beginning and end of the intervention trial (Day 0 and week 12)]
5. Assessing lipid profile (Safety) [At the beginning and end of the intervention trial (Day 0 and week 12)]
6. Assessing glucose (Safety) [At the beginning and end of the intervention trial (Day 0 and week 12)]
7. Measuring thyroid-stimulating hormone (TSH) to assess thyroid function (Safety) [At the beginning and end of the intervention trial (Day 0 and week 12)]
8. Measuring alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin (Bil) to assess liver function (Safety) [At the beginning and end of the intervention trial (Day 0 and week 12)]
9. Measuring creatinine (Cr), urine (Ur) and blood urea nitrogen (BUN) to assess renal function (Safety) [At the beginning and end of the intervention trial (Day 0 and week 12)]
10. Evaluating electrocardiogram (ECG) and heart rhythm to assess heart function (Safety) [At the beginning and end of the intervention trial (Day 0 and week 12)]
11. Measuring creatinine phosphokinase (CPK) to detect muscle damage (Safety) [At the beginning and end of the intervention trial (Day 0 and week 12)]
