N18.89
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Inclusion criteria for study participants in groups 1 and 3 (group 1: “Patients with chronic kidney disease”; group 3: “Healthy control subjects”) are additionally age 18–60 years, (relatively) good general health, and normal nutritional status. • For group 1, “Patients with chronic kidney disease,” a glomerular filtration rate of 20–50 ml/min/1.73 m2 is an additional requirement for inclusion. • For group 2, “Patients with chronic kidney disease due to aggregate-forming GATM mutations,” the presence of an aggregate-forming GATM mutation is a prerequisite for inclusion.
Exclusion criteria
Exclusion criteria: • Metabolic disorders • Liver disease • Body mass index 35 • Muscular or nervous system disorders • Gastrointestinal disorders • Heart disease • Arterial hypertension • Malignant disorders • Psychiatric disorders • Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| There are no endpoints in the traditional sense in this study. Therefore, the objectives of the study are included here: 1. Study objective “Creatine metabolism and kidney function” Investigation of creatine metabolism prior to supplementation and the effects of supplementation with creatine (at least 3 months) on creatine metabolism and kidney function in patients with chronic kidney disease, in patients with chronic kidney disease due to aggregate-forming GATM mutations, and in healthy individuals, as well as dose determination (for creatine) in individuals with impaired kidney function. Parameters recorded (3x without creatine supplementation, at least 3x with creatine supplementation): Creatine, guanidoacetate, creatinine, glucose, and amino acids in serum and urine GFR estimation by creatinine and cystatin C clearance 2. Study objective “well-being” Investigation of the effects of creatine supplementation on the well-being of patients with chronic kidney disease, patients with chronic kidney disease caused by aggregate-forming GATM mutations, and healthy individuals. Measurement method: Questionnaire without creatine supplementation and after 3 months of creatine supplementation 3. Study objective: “Slowing the progression of the disease in patients with aggregate-forming GATM mutations” Investigation of the effects of creatine supplementation on the progression of kidney disease in patients with chronic kidney disease caused by aggregate-forming GATM mutations. Parameters recorded (3x without creatine supplementation, at least 3x with creatine supplementation): GFR estimation by creatinine and cystatin C clearance Measurement of amino acid, protein, glucose, and phosphate excretion | — |
Countries
Germany, United Kingdom, United States
Contacts
Universität Regensburg, Medizinische Zellbiologie