Pentoxifylline Effect in Patients With Diabetic Nephropathy.(PENFOSIDINE STUDY)
Кључне речи
Апстрактан
Опис
Patients will be randomly selected from the outpatient family medicine clinics. Once included, patients will be randomly allocated (by a computer-generated randomization list) to a study or control group. Over a period of 2 years, patients of the study group will receive one PTX tablet (400 mg) orally three times a day (at dinner time), whereas controls will receive one cellulose identical tablet on the same schedule.
All patients will continue with their usual treatment prescribed by their family doctor. Monthly visits will be scheduled for clinical and biochemical evaluations. A blood sample will be taken at baseline and every six months up to 24 months, for measurement of complete blood count, urea, creatinine, glucose, albumin, lipids, electrolytes, liver function tests, serum total proteins, (will be measure by usual methods). In serum samples at 0, 6, 12, 18 and 24 months, high sensibility C reactive protein will be measured by nephelometry, Brain natriuretic peptide and Serum Cystatin C will be measured by ELISA. Glomerular filtration rate (GFR) will be calculated based in Cystatin C level Grubb's equations. Vitamin C will be measured by HPLC. A 24 h ambulatory blood pressure monitoring (24 h ABPM), M-mode and two-dimensional echocardiographic, and an analysis of body composition by bioelectrical impedance will be done at baseline 6, 12, 18 and 24 months. To investigate health-related quality of life the short-form 36 (SF-36) questionnaire will be applied. Treatment compliance will be recorded by counting tablets left in the container at the end of each monthly visit and by the Morinsky Green test.
Датуми
| Последња верификација: | 01/31/2019 |
| Фирст Субмиттед: | 07/24/2018 |
| Предвиђена пријава послата: | 09/05/2018 |
| Прво објављено: | 09/09/2018 |
| Послато последње ажурирање: | 02/05/2019 |
| Последње ажурирање објављено: | 02/06/2019 |
| Стварни датум почетка студије: | 02/28/2018 |
| Процењени датум примарног завршетка: | 07/29/2019 |
| Предвиђени датум завршетка студије: | 12/30/2021 |
Стање или болест
Интервенција / лечење
Drug: pentoxifylline
Фаза
Групе руку
| Арм | Интервенција / лечење |
|---|---|
| Placebo Comparator: Placebo group Placebo group will receive 1 tablet of cellulose pill to mimic pentoxifylline tablets three times a day with meals, during the following two years. | |
| Active Comparator: Pentoxifylline group Pentoxifillyne or experimental group will receive 400 mg of pentoxifylline three times a day with meals, during the following two years. |
Критеријуми
| Узраст подобан за студирање | 30 Years До 30 Years |
| Полови подобни за студирање | All |
| Прихвата здраве волонтере | да |
| Критеријуми | Inclusion Criteria: 1. CKD 2. Type 2 diabetes mellitus 3. Microalbuminuria 4. Proteinuria. 5. Creatinine plasma clearance ˂ of 60 mL / min. Exclusion criteria: 1. History of psychiatric disorders, 2. Immunosuppressants treatment 3. Herbalism Treatment 4. History of chronic alcoholism. 5. Type 1 diabetes mellitus. 6. Chronic obstructive pulmonary disease. 7. Pulmonary fibrosis 8. Heart failure 9. HIV-AIDS. 10. Liver cirrhosis. 11. Chronic hepatitis. |
Исход
Примарне мере исхода
1. Change in the glomerular filtration rate [The measurements will be done baseline and every six months up to 24 months.]
Секундарне мере исхода
1. Change in oxidative stress marker. [Change is assessed baseline, 6 months, 12 months, 18 months and 24 months.]
2. Change in fibrosis markers. [Change is assessed baseline, 6 months, 12 months, 18 months and 24 months.]
3. Change in inflammation markers. [Change is assessed baseline, 6 months, 12 months, 18 months and 24 months.]
4. Change in health-related quality of life [The questionnaire will be applied baseline and every six months up to 24 months.]
