scholarly journals PRODIG (Prevention of new onset diabetes after transplantation by a short term treatment of Vildagliptin in the early renal post-transplant period) study: study protocol for a randomized controlled study

2019 ◽  
Author(s):  
Emilie Gaiffe ◽  
Thomas Crepin ◽  
Jamal Bamoulid ◽  
Cécile Courivaud ◽  
Matthias Büchler ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Kidney Transplantation ◽  
High Risk ◽  
Term Treatment ◽  
Short Term ◽  
Short Term Treatment ◽  
Post Transplant ◽  
Transplant Patients ◽  
New Onset

Abstract Background: Post-transplant diabetes is a frequent and serious complication of kidney transplantation. There is currently no treatment to prevent or delay the disease. Nevertheless, identification of risk factors make possible to target a population at risk to develop de novo diabetes. We hypothesized that a short term treatment with Vildagliptin may prevent new onset diabetes after transplantation (NODAT) in high-risk patients. Method/design: This is a multicenter double-blind placebo-controlled randomized clinical trial. Patients undergoing first kidney transplantation will be included in 10 French transplant center. Included patients will be randomized (1:1) to receive either vildagliptin 100 or 50 mg/day (depending on glomerular filtration rate) during 2 months (the first dose being administered before entering the operating theatres) or placebo. Additional antidiabetic therapy could be administered according to glycemic control. The primary outcome is the proportion of diabetic patients 1 year after transplantation, defined as patients receiving a diabetic treatment, or having a fasting glucose above 7 mmol/l, or/and with an abnormal oral glucose tolerance test. Secondary outcomes include the glycated hemoglobin, the occurrence of acute rejection, infection, graft loss and patient death at 3 months, 6 months and 12 months after transplantation. Outcomes will be correlated to clinical and general characteristics of the patient, cardiovascular history, nephropathy, dialysis history, transplantation data, biological data, the health-related quality of life and the cost-effectiveness of prevention of diabetes with vildagliptin. Discussion: There are only few data concerning pharmacological prevention of post-transplant diabetes. If our hypothesis is verified, our results will have a direct application in clinical practice and could limit diabetes-associated morbidity, reduce cardiovascular complications, increase quality of life of renal transplant patients, and consequently promote graft and patient survival. Our results may possibly serve for non-transplant patients carrying a high-risk of diabetes associated with other co-morbidities. Trial registration: ClinicalTrials.gov, NCT02849899 Registered on 8 February 2016.

scholarly journals PRODIG (Prevention of new onset diabetes after transplantation by a short term treatment of Vildagliptin in the early renal post-transplant period) study study protocol for a randomized controlled study

2019 ◽  
Author(s):  
Emilie Gaiffe ◽  
Thomas Crepin ◽  
Jamal Bamoulid ◽  
Cécile Courivaud ◽  
Matthias Büchler ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Kidney Transplantation ◽  
Term Treatment ◽  
Short Term ◽  
Short Term Treatment ◽  
Post Transplant ◽  
Randomized Controlled ◽  
Transplant Patients ◽  
New Onset

Abstract Background: Post-transplant diabetes is a frequent and serious complication of kidney transplantation. There is currently no treatment to prevent or delay the disease. Nevertheless, identification of risk factors make possible to target a population at risk to develop de novo diabetes. We hypothesized that a short term treatment with Vildagliptin may prevent new onset diabetes after transplantation (NODAT) in high-risk patients. Methods: This is a multicenter double-blind placebo-controlled randomized clinical trial. Patients undergoing first kidney transplantation will be included in 10 French transplant center. Included patients will be randomized (1:1) to receive either vildagliptin 100 or 50 mg/day (depending on glomerular filtration rate) during 2 months (the first dose being administered before entering the operating blocks) or placebo. Additional antidiabetic therapy could be administered according to glycemic control. The primary outcome is the proportion of diabetic patients 1 year after transplantation, defined as patients receiving a diabetic treatment, or having a fasting glucose above 7 mmol/l, or/and with an abnormal oral glucose tolerance test. Secondary outcomes include the glycated hemoglobin, the occurrence of acute rejection, infection, graft loss and patient death at 3 months, 6 months and 12 months after transplantation. The results will be correlated to clinical and general characteristics of the patient, cardiovascular history, nephropathy, dialysis history, transplantation data, biological data, the health-related quality of life and the cost-effectiveness of prevention of diabetes with vildagliptin. Discussion: There are only few data concerning pharmacological prevention of post-transplant diabetes. If our hypothesis is verified, our results will have a direct application in clinical practice and could limit diabetes-associated morbidity, reduce cardiovascular complications, increase quality of life of renal transplant patients, and consequently promote graft and patient survival. Our results may possibly serve for non-transplant patients carrying a high-risk of diabetes associated with other co-morbidities. Trial registration: ClinicalTrials.gov, NCT02849899 Registered on 8 February 2016. Keywords: Diabetes prevention; Vildagliptin; kidney transplantation; randomized controlled trial.

scholarly journals PRODIG (Prevention of new onset diabetes after transplantation by a short term treatment of Vildagliptin in the early renal post-transplant period) study: study protocol for a randomized controlled study

2019 ◽  
Author(s):  
Emilie Gaiffe ◽  
Thomas Crepin ◽  
Jamal Bamoulid ◽  
Cécile Courivaud ◽  
Matthias Büchler ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Kidney Transplantation ◽  
Term Treatment ◽  
Short Term ◽  
Short Term Treatment ◽  
Post Transplant ◽  
Randomized Controlled ◽  
Transplant Patients ◽  
New Onset

Abstract Background: Post-transplant diabetes is a frequent and serious complication of kidney transplantation. There is currently no treatment to prevent or delay the disease. Nevertheless, identification of risk factors make possible to target a population at risk to develop de novo diabetes. We hypothesized that a short term treatment with Vildagliptin may prevent new onset diabetes after transplantation (NODAT) in high-risk patients. Method/design: This is a multicenter double-blind placebo-controlled randomized clinical trial. Patients undergoing first kidney transplantation will be included in 10 French transplant center. Included patients will be randomized (1:1) to receive either vildagliptin 100 or 50 mg/day (depending on glomerular filtration rate) during 2 months (the first dose being administered before entering the operating theatres) or placebo. Additional antidiabetic therapy could be administered according to glycemic control. The primary outcome is the proportion of diabetic patients 1 year after transplantation, defined as patients receiving a diabetic treatment, or having a fasting glucose above 7 mmol/l, or/and with an abnormal oral glucose tolerance test. Secondary outcomes include the glycated hemoglobin, the occurrence of acute rejection, infection, graft loss and patient death at 3 months, 6 months and 12 months after transplantation. Outcomes will be correlated to clinical and general characteristics of the patient, cardiovascular history, nephropathy, dialysis history, transplantation data, biological data, the health-related quality of life and the cost-effectiveness of prevention of diabetes with vildagliptin. Discussion: There are only few data concerning pharmacological prevention of post-transplant diabetes. If our hypothesis is verified, our results will have a direct application in clinical practice and could limit diabetes-associated morbidity, reduce cardiovascular complications, increase quality of life of renal transplant patients, and consequently promote graft and patient survival. Our results may possibly serve for non-transplant patients carrying a high-risk of diabetes associated with other co-morbidities. Trial registration: ClinicalTrials.gov, NCT02849899 Registered on 8 February 2016. Keywords: Diabetes prevention; Vildagliptin; kidney transplantation; randomized controlled trial.

Health-Related Quality of Life Under Six Months' Treatment of Migraine-An Open Clinic-Based Longitudinal Study

Cephalalgia ◽  
1995 ◽  
Vol 15 (5) ◽  
pp. 414-422 ◽  
Author(s):  
CGH Dahlöf
Keyword(s):  
Quality Of Life ◽  
Well Being ◽  
Term Treatment ◽  
Health Related Quality ◽  
Short Term ◽  
Short Term Treatment ◽  
Related Quality ◽  
Health Related ◽  
The Impact

Health-related quality of life (HQL) assessment in the clinical setting have distinguished subjective perceptions (e.g. well-being), signs/symptoms of the disease, and functional capacity as three major components. The impact of short-term treatment for migraine attacks on these variables was evaluated in an open prospective 6-month study at the Gothenburg Migraine Clinic. Socio-economic factors, subjective symptoms, and general well-being/quality of life were evaluated by self-administered questionnaires in 99 patients with migraine with or without aura in accordance with the classification of the International Headache Society. Short-term treatment comprising conventional therapy or subcutaneous sumatriptan reduced number of days per month with migraine and absenteeism from work, migraine-associated symptoms, but did not significantly improve general well-being between attacks. Future assessment of the patients' HQL in accordance with this approach would enable us to consider all the advantages and disadvantages of current therapies of particular interest in the field of migraine.

The Efficacy of Short-Term Treatment for Improving Quality of Life

1996 ◽  
Vol 184 (8) ◽  
pp. 507-508 ◽  
Author(s):  
Sharon G. Dott ◽  
David P. Walling ◽  
Sheryl L. Bishop ◽  
Jayne E. Bucy ◽  
Cheryl C. Folkes
Keyword(s):  
Quality Of Life ◽  
Term Treatment ◽  
Short Term ◽  
Short Term Treatment

scholarly journals Quality of life and spirituality of patients with chronic kidney disease: pre- and post-transplant analysis

2020 ◽  
Vol 73 (suppl 5) ◽  
Author(s):  
Letícia Meazzini de Olivera ◽  
Meiry Fernanda Pinto Okuno ◽  
Dulce Aparecida Barbosa ◽  
Ricardo de Castro Cintra Sesso ◽  
Gerson Scherrer Júnior ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Kidney Disease ◽  
Peritoneal Dialysis ◽  
Kidney Disease ◽  
Kidney Transplant ◽  
Disease Burden ◽  
Four Dimensions ◽  
Post Transplant ◽  
Transplant Patients

ABSTRACT Objective: to compare the quality of life (QoL) of patients under dialysis and after kidney transplant; correlate the QoL of transplant patients to sociodemographic, morbid and spirituality/religiosity variables. Method: prospective study with a quantitative approach, with a sample of 27 patients who underwent peritoneal dialysis or dialysis undergoing kidney transplant. QoL and spirituality were assessed by the KDQOL-SF and WHOQOL-SRPB tools, being correlated with sociodemographic and economic variables. Results: the dimensions of total mental component, kidney disease effects and kidney disease burden showed significant improvement in the post-transplant period, with p <0.0004. There was a significant correlation between four dimensions of spirituality and seven dimensions of QoL; p ranged from 0.04 to 0.006. Conclusion: there was a significant improvement in QoL in the post-transplant period. The dimensions of spirituality: wholeness and integration, spiritual connection, wonder and inner peace were positively correlated with seven dimensions of QoL.

Evaluation of Quality of Life among Kidney Transplant Patients- A Cross Sectional Study

2021 ◽  
Vol 15 (11) ◽  
pp. 3087-3089
Author(s):  
Rashida Jabeen ◽  
Kousar Perveen ◽  
Muhammad Afzal ◽  
Sadia Khan
Keyword(s):  
Quality Of Life ◽  
Kidney Transplantation ◽  
Kidney Transplant ◽  
Cross Sectional Study ◽  
P Value ◽  
Sectional Study ◽  
Cross Sectional ◽  
Transplant Patients ◽  
Kidney Transplant Patients

Kidney transplantation is the famous and most important choice of treatment of renal replacement therapies (RRTs) because of its positive impact on morbidity, survival and cost. The health related quality of life is becoming important outcome. Quality of life is usually impaired in patients who have renal transplant because of renal transplant patients have anxiety, lack of social, physical and emotional support and diminished ability to take care of themselves. The basic purpose of renal transplantation is to achieve maximum quality of life with minimum side effects. Methods: A cross sectional study was conducted at Rukhsana Akhtar Bahria International Orchard Hospital Lahore after approval from institution board of university of Lahore. 36 patients were enrolled in study by using purposive sampling technique. After taking informed consent all Kidney transplant patients aged between 18 years to 60 years, visited the post-transplantation OPD and continuously in follow-up sessions were included in study. A validated and standard WHO questionnaire of “Kidney Disease and Quality of Life (KDQOL-36™)” was used for data collection. Data was entered and analyzed in SPSS version.21.Chi-square test was applied to find out significant association between qualitative variables. P -Value < 0.05will be considered as statistically significant. Results: Majority of patients were from 40-49 years 10(27.0%). Females were more as compared to men (20(55.6) vs 16(44.4%)). 10(27.8) patients can read and write and 8(22.2%) have done matriculation. More patients live in Urban area as compared to rural area(19(52.8%) vs 17(47.2%)).8(22.2%) patients have less than 1 year of post kidney transplantation time and 19(52.8%) have 1 to 3 years. All the seven domains of KDQOL show poor QOL. General Health, Physical function and physical and emotional function shows average QOL and Emotional, social, daily activities and overall KDQOL shows poor QOL. There was insignificant association with age, gender, education; residential area and Post kidney transplantation length of time (years)(p-value > 0.05). Conclusions: After renal transplantation HRQOL becomes very important factor. After kidney transplantation HRQOL depends on many factors. It was concluded from current study that the HRQOL was not as good as it should be. Over the period of transplantation time patient’s quality of life remain same. The society, government, family, and medical staff need to support patients so they can also improve their QOL. Key word: Renal Diseases, Kidney transplant, Quality of life, KDQOL-36

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