Impact of low protein diet supplemented with ketoanalogues on uremic toxins production and glucose metabolism in chronic kidney disease_KETO GUT study - KETO-GUT

Hospices Civils de Lyon0 个研究点目标入组 85 人开始时间: 2019年6月5日最近更新: 2020年8月10日

适应症

试验速览

暂无简介。

•- Age between 18 and 80 years
•-CKD stage 4-5 with estimated glomerular filtration rate < 30 ml/min/1,73m2
•-No dialysis
•- No history of kidney transplantation
•- Non-diabetic (fasting glucose <1.26 g / L, or no insulin or oral antidiabetic therapy)
•-BMI between 18 and 30 kg / m²
•-Patient followed in the nephrology department of Professor FOUQUE at the Lyon Sud hospital
•- For women of childbearing age, at least one method of contraception recognized as effective
•-Patient who gave consent to open participation and signed the consent to participate in the study
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 45
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•-Patient with progressive inflammatory, infectious, cardiovascular or neoplastic disease
•- Patient refusing a dietary follow-up
•-Patient having a planned transplant or dialysis project in the next 6 months.
•- Patient having a colectomy, resection of the small intestine or cholecystectomy
•-Patient who has received antibiotics, prebiotics, probiotics in the last 3 months.
•- Patient treated with more than 2 g of calcium per day
•-Patient using laxatives (more than 2 per day)
•-Patient having:
•o Uncontrolled metabolic acidosis (bicarbonatemia <18 mM)
•o Hyperparathyroidism (PTH greater than 5 times the upper limit of normal)
•o Hypercalcemia (Calcium> 2.55 mmol / L) or hypophosphoremia <0.70 mmol / L
•o Anemia (hemoglobinemia <80g / L)
•o Undernutrition criteria: albumin <38 g / L or prealbumin <0.3 g / L
•-Known hypersensitivity to any of the substances or excipients of Ketosteril?
•- Subject in exclusion period of a previous study
•- Patient not affiliated to social security
•--atient under guardianship or in the interests of justice
•-Patient who is pregnant, breastfeeding or likely to become pregnant during the study

发起方