Insulin Resistance and Statin Treatment in Renal Transplant Recipients and Patients with Chronic Kidney Disease
- Conditions
- Insulin resistanceTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- CTIS2022-501068-16-00
- Lead Sponsor
- Aarhus University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
STUDY 1: 1) Age 40-70 years; 2) BMI 20-30 kg/m2; 3) Renal transplantation > 6 months prior to inclusion; 4) Combination immunosuppressive treatment with mycophenolate, tacrolimus, and prednisolone; 5) eGFR > 29 ml/min; 6) Written, informed consent prior to study inclusion, STUDY 2: 1) Age 40-70 years; 2) BMI 20-30 kg/m2; 3) Chronic kidney disease stage 3 i.e., eGFR > 29 ml/min and < 60 ml/min; 4) Written, informed consent prior to study inclusion
STUDY 1: 1) Pre-existing diabetes mellitus; 2) Clinic blood pressure > 160/100 mmHg; 3) Regular treatment with doses of prednisolone > 5 mg daily; 4) Treatment with prednisolone > 15 mg/day for > 5 days, for any reason within 3 months prior to inclusion; 5) Average change in eGFR of > 5 mL/min estimated over 3 months prior to screening; 6) Blood tacrolimus level continuously outside target range; 7) Known allergy towards study medication; 8) Treatment with any type of statin as secondary prophylaxis following a cardiovascular event; 9) Prior, severe reaction to or severe side effect from any type of statin; 10) Active or chronic liver disease with serum concentration of ALAT > thrice the upper limit of normal (ULN), or spontaneous INR > 1,5; 11) Pre-existing myositis; 12) Plasma CK concentration > 4 times the ULN; 13) Hereditary galactose intolerance or known glucose/galactose malabsorption; 14) Any other organ transplantation prior to or during the trial; 15) Pregnancy or breastfeeding or unable or unwilling to use secure contraception to avoid pregnancy (female participants only); 16) Inability to understand the spoken and written information given and/or inability to give informed consent; 17) Being under legal guardianship, STUDY 2: 1) Pre-existing diabetes mellitus; 2) Clinic blood pressure > 160/100 mmHg; 3) Treatment with antidiabetic medication, other than SGLT2-inhibitors for cardio- or renal protective purposes only, and GLP-1 analogs for weight reduction purposes only; 4) Treatment with glucocorticoids or other immunosuppressive medication of any kind; 5) Known allergy towards study medication; 6) Treatment with any type of statin as secondary prophylaxis following a cardiovascular event; 7) Prior, severe reaction to or severe side effect from any type of statin; 8) Active or chronic liver disease with serum concentration of ALAT > thrice the ULN, or spontaneous INR > 1,5; 9) Pre-existing myositis from any cause; 10) Plasma CK concentration > 4 times the ULN; 11) Hereditary galactose intolerance or known glucose/galactose malabsorption; 12) Any organ transplantation prior to or during the trial; 13) Pregnancy or breastfeeding or unable or unwilling to use secure contraception to avoid pregnancy (female participants only); 14) Inability to understand the spoken and written information given and/or inability to give informed consent; 15) Being under legal guardianship
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effect of Pravastatin on insulin sensitivity compared to placebo.;Secondary Objective: To evaluate the effect of Pravastatin on insulin secretion, hormone levels and apllicability of surroate indices for insulin sensitivity, Assess the effect of Pravastatin on insulin signalling pathways on the level of gene and protein expression, Assess changes in faecal microbiota composition following treatment with Pravastatin;Primary end point(s): Insulin sensitivity assessed by hyperinsulinemic euglycemic glucose clamp
- Secondary Outcome Measures
Name Time Method