Curcumin in Kidney Transplant Recipients
Ключови думи
Резюме
Описание
Kidney transplant recipients are at increased risk of death from cardiovascular disease (CVD). Inflammation, oxidative stress and vascular dysfunction (impaired endothelial function and increased large elastic artery stiffness), are highly prevalent in kidney transplant recipients and contribute to the high incidence of CVD in this patient population. The most common cause of kidney transplant failure is interstitial fibrosis and tubular atrophy (IFTA). The incidence of IFTA is as high as 50% of kidney transplants at 1 year after transplantation. The pathophysiology of IFTA is not well understood. Possible mechanisms include chronic rejection or injury, inflammation, and drug toxicity. Kidney transplant recipients suffer from high rates of cognitive decline for which the investigators lack effective therapies. Thus, therapeutic interventions targeting inflammation, oxidative stress, vascular dysfunction, and cognitive impairment are a priority.
Curcumin may have positive effects in terms of cardiovascular and nephroprotection because of its antibacterial, antiviral, anti-inflammatory and anti-oxidative effects. The aim of this study is to elucidate the role of curcumin as a nutritional strategy to reduce cardiovascular risk factors as well as inflammation and oxidative stress in kidney transplant recipients. The study aims to examine if curcumin will improve endothelial function by reducing markers of inflammation and oxidative stress. In addition, the study will evaluate the potential benefit of curcumin on cognitive function in kidney transplant recipients.
Curcumin is a natural polyphenol with anti-inflammatory and antioxidant characteristics. Preliminary data indicate that curcumin administration improves endothelial dysfunction by reducing oxidative stress and inflammation and may improve cognitive function.
The primary goal of this study is to investigate if curcumin is beneficial for kidney transplant recipients, a population with extensive baseline vascular dysfunction and cognitive impairment who have few treatment options. The possible mechanisms by which curcumin improves vascular function will be evaluated as well as whether curcumin improves cognitive function in these patients.
Objectives:
1. Evaluate the effects of curcumin on kidney transplant graft function
2. Evaluate the effects of curcumin supplementation on cognitive function.
3. Evaluate the effects of curcumin on diabetes and cardiovascular outcomes
4. Evaluate the effects of curcumin on systemic and endothelial cell markers of inflammation and oxidative stress.
Methods:
Patients will be randomized 1:1 to receive either curcumin or placebo starting at the time of transplant or up to 2 weeks prior to transplant. Patients will be followed per standard of care for kidney transplant recipients. Additional blood (30mL) and urine samples will be drawn prior to transplant and at 3, 6 and 12 months post-transplant to be used for future analysis. There will be a total of 4 visits for this study. Additionally, two questionnaires will be distributed at each visit.
Дати
| Последна проверка: | 03/31/2020 |
| Първо изпратено: | 04/22/2019 |
| Очаквано записване подадено: | 04/29/2019 |
| Първо публикувано: | 05/01/2019 |
| Изпратена последна актуализация: | 04/19/2020 |
| Последна актуализация публикувана: | 04/20/2020 |
| Действителна начална дата на проучването: | 10/31/2019 |
| Приблизителна дата на първично завършване: | 04/30/2022 |
| Очаквана дата на завършване на проучването: | 04/30/2023 |
Състояние или заболяване
Интервенция / лечение
Dietary Supplement: Curcumin Arm (Arm 1)
Other: Placebo Arm (Arm 2)
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: Curcumin Arm (Arm 1) 20 subjects will be randomized (1:1) to this arm and receive curcumin for a year. In addition, subjects will have four study visits at Day 0, and 3, 6 and 12 months post-transplant. These study visits also include blood and urine samples and questionnaires. | Dietary Supplement: Curcumin Arm (Arm 1) Patients will receive curcumin (Longvida) 2000 mg, once a day, for 12 months |
| Placebo Comparator: Placebo Arm (Arm 2) 20 subjects will be randomized (1:1) to this arm and receive placebo for a year. In addition, subjects will have four study visits at Day 0, and 3, 6 and 12 months post-transplant. These study visits also include blood and urine samples and questionnaires. | Other: Placebo Arm (Arm 2) Patients will receive placebo capsule identical in appearance and taste to the supplement, for 12 months |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: 1. The subject is a recipient of a living donor or deceased donor kidney only transplant 2. The subject is > 18 years of age Exclusion Criteria: 1. The subject has had a multi-organ transplant 2. Subjects that were taking curcumin pre-transplant 3. Subjects that have a BMI > 35 kg/m2 |
Резултат
Първични изходни мерки
1. Graft Outcomes [12 months]
2. Diabetes Outcomes [12 months]
3. Cardiovascular Outcomes [12 months]
4. Cognitive function [12 months]
5. Graft Outcomes [12 months]
6. Cognitive function [12 months]
7. Cardiovascular Outcomes [12 months]
