Type 2 Diabetes Mellitus Clinical Trial
Official title:
Pentoxifylline Effect on Renal Function, Oxidative Stress, Inflammation, and Fibrosis Markers, and Quality of Life in Patients With Diabetic Nephropathy
One of the purposes of the management of the patient with chronic kidney disease (CKD)is to
slow the decline of renal function. The mechanisms by which the renal function declines
involve inflammatory and fibrotic responses due in part by the effects of oxidative stress.
Pentoxifylline (PTX)is a drug that stimulates adenosine receptors, and produces inhibition of
phosphodiesterases, as well as being a dopaminergic modulator through D1 and D2 receptors.
Its main effects are inhibition of the inflammatory state by decreasing serum levels of tumor
necrosis factor alpha (TNF-ɒ) and monocyte chemo attractant protein 1 (MCP_1), which may slow
down the decline of renal function. It also produces diminish of sympathetic activity, with
the reduction of circulating levels of norepinephrine (NA), which may contribute to the
reduction of glomerulosclerosis in diabetic patients. In the connective tissue increases the
activity of the collagenases and decrease of collagen, fibronectin and glucosamine of the
fibroblasts as well as inhibition of oxygen free radicals. Due to its antioxidant,
anti-inflammatory and anti-fibrotic effects, PTX can result in an excellent therapeutic
option for the prevention of CKD in DM2.
This work proposes the use of pentoxifylline as treatment CKD in DM2. Its application in
patients with CKD will allow a therapeutic management with different targets, for its
antioxidant, anti-inflammatory and antifibrotic effects that will be evaluated by means of
fibrosis, inflammation and oxidative stress markers. The results will be of great importance
in clinical practice, since they will justify the use of a new pharmacological tool, already
known, with minimal adverse effects and low cost, accessible to all strata of the population
since it is found as generic.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02771093 -
An Exploratory Study of the Effects of Trelagliptin and Alogliptin on Glucose Variability in Patients With Type 2 Diabetes Mellitus
|
Phase 4 | |
| Completed |
NCT02545842 -
Assessment Study of Three Different Fasting Plasma Glucose Targets in Chinese Patients With Type 2 Diabetes Mellitus (BEYOND III/FPG GOAL)
|
Phase 4 | |
| Recruiting |
NCT03436212 -
Real-Life Home Glucose Monitoring Over 14 Days in T2D Patients With Intensified Therapy Using Insulin Pump.
|
N/A | |
| Completed |
NCT03244800 -
A Study to Investigate Different Doses of 0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.
|
Phase 2 | |
| Completed |
NCT03960424 -
Diabetes Management Program for Hispanic/Latino
|
N/A | |
| Withdrawn |
NCT02769091 -
A Study in Adult Patients With Nonalcoholic Steatohepatitis Who Also Have Type 2 Diabetes
|
Phase 2 | |
| Recruiting |
NCT06065540 -
A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor
|
Phase 3 | |
| Recruiting |
NCT05008276 -
Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)
|
||
| Completed |
NCT04091373 -
A Study Investigating the Pharmacokinetics of a Single Dose Administration of Cotadutide
|
Phase 1 | |
| Completed |
NCT03296800 -
Study to Evaluate Effects of Probenecid, Rifampin and Verapamil on Bexagliflozin in Healthy Subjects
|
Phase 1 | |
| Recruiting |
NCT06212778 -
Relationship Between Nutritional Status, Hand Grip Strength, and Fatigue in Hospitalized Older Adults With Type 2 Diabetes Mellitus.
|
||
| Completed |
NCT05979519 -
Fresh Carts for Mom's to Improve Food Security and Glucose Management
|
N/A | |
| Recruiting |
NCT05579314 -
XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)
|
Phase 1 | |
| Completed |
NCT03859934 -
Metabolic Effects of Melatonin Treatment
|
Phase 1 | |
| Terminated |
NCT03684642 -
Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
|
Phase 3 | |
| Completed |
NCT03248401 -
Effect of Cilostazol on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes
|
Phase 4 | |
| Completed |
NCT03644134 -
A Personalized Intervention to Manage Physiological Stress and Improve Sleep Patterns
|
N/A | |
| Completed |
NCT05295160 -
Fasting-Associated Immune-metabolic Remission of Diabetes
|
N/A | |
| Completed |
NCT02836873 -
Safety and Efficacy of Bexagliflozin in Type 2 Diabetes Mellitus Patients With Moderate Renal Impairment
|
Phase 3 | |
| Completed |
NCT02252224 -
Forxiga (Dapagliflozin) Regulatory Postmarketing Surveillance
|