Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Didac Mauricio, Md PhD
CONTACT
Josep Julve, PhD
CONTACT
Lead
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
With
Patients with a Fibroscan \> 8 kPa will be offered to participate in this study. Participants will receive either placebo or a NAM dose adjusted to body weight. The duration of the treatment is 12 months. Participants will be subjected to a total of 5 follow-up and/or control visits: Visit 1 * Physical examination(weight, height, BMI, waist circumference, neck circumference, blood pressure, and heart rate). * Assessment of muscle status and risk of sarcopenia: grip strength, chair test. * Basal electrocardiogram. * Blood analysis. * Bioelectrical impedance analysis. * Nuclear magnetic resonance. * Thermographic image. * Food questionnaire (PREDIMED). * International Physical Activity Questionnaire (IPAQ). * Collection of blood, urine, and feces samples for storage in the biobank. Visit 2. Control visit (time month 1) * Monitoring of adverse events (AE) and adverse reactions (AR). * Electrocardiogram. * Control blood analysis: sodium, potassium, liver biochemistry (AST, ALT, bilirubin, GGT, FA), renal function (urea, creatinine, estimated glomerular filtration), and coagulation tests. * Physical examination and measurement of vital signs. Visit 3. Follow-up visit (time month 3) * Monitoring of AE and AR. * Drug adherence questionnaire. * Electrocardiogram. * Blood analysis. * Physical examination (weight, BMI, waist circumference, neck circumference, blood pressure, and heart rate). * Collection of blood, urine, and feces samples for biobank. * Collection of concomitant medication. * Adherence to study treatment and dietary recommendations. Visit 4. Follow-up visit (time month 6) * Monitoring of AE and AR. * Drug adherence questionnaire. * Electrocardiogram. * Blood analysis. * Physical examination (weight, BMI, waist circumference, neck circumference, blood pressure, and heart rate). * Collection of blood, urine, and feces samples for biobank. * Collection of concomitant medication. * Adherence to study treatment and dietary recommendations. Visit 5. Control visit (time month 9). * Monitoring of AE and AR. * Drug adherence questionnaire. * Electrocardiogram. * Control blood analysis. * Physical examination. * Collection of concomitant medication. Visit 6. Final exploration (time month 12) * Monitoring of AE and AR. * Drug adherence questionnaire. * Food questionnaire (PREDIMED). * Physical Activity Questionnaire (IPAQ). * Physical examination and measurement of vital signs (weight, BMI, waist circumference, neck circumference, blood pressure, and heart rate). * Assessment of muscle status and risk of sarcopenia: FPM, chair test. * Electrocardiogram. * Blood analysis. * Measurement of NAM and derived metabolites in serum and urine. * Nuclear magnetic resonance. * Bioimpedance. * Thermographic image. * Fibroscan® with CAP. * Collection of blood, urine, and feces samples for biobank The safety of the participants will be assessed using a record of the AEs and ARs that could arise and their annotation in the EDC, as well as a regular evaluation of liver, kidney, and heart function at baseline, 1, 3, 6, 9 and 12 months
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
