Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599918
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Study of the Efficacy and Safety of Nicotinamide in Patients with Diabetes Mellitus Type 2 and Liver Fibrosis NICOFIB
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Double-blind Placebo-controlled Study of the Efficacy and Safety of Nicotinamide in Patients with Diabetes Mellitus Type 2 and Liver Fibrosis NICOFIB
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NICOFIB
Brief Summary:
The objective of this clinical trial a pilot study is to assess the impact of nicotinamide NAM on individuals with hepatic fibrosis
The main question it aims to answer is
- To determine if the treatment with NAM is able to arrest or even reduce the hepatic fibrosis
In addition we also want to study the effect of NAM on
General parameters weight HOMA-IR etc
Adiposity distribution liver and body
Systemic inflammation
Thermogenic capacity of adipose tissue
Microbiota composition
Researchers will compare NAM to a placebo to see if NAM can arrest or revert hepatic fibrosis and its associated effects
Participants will take either NAM or placebo The dosage will be 12gm2 NAM per day for one year
The main question it aims to answer is
- To determine if the treatment with NAM is able to arrest or even reduce the hepatic fibrosis
In addition we also want to study the effect of NAM on
General parameters weight HOMA-IR etc
Adiposity distribution liver and body
Systemic inflammation
Thermogenic capacity of adipose tissue
Microbiota composition
Researchers will compare NAM to a placebo to see if NAM can arrest or revert hepatic fibrosis and its associated effects
Participants will take either NAM or placebo The dosage will be 12gm2 NAM per day for one year
Detailed Description:
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 andor control visits
Visit 1
Physical examinationweight 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
Liver ultrasound
Ultrasound of abdominal and preperitoneal fat
Musculoskeletal ultrasound
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
Liver ultrasound
Ultrasound of abdominal and preperitoneal fat
Musculoskeletal ultrasound
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
Participants will be subjected to a total of 5 follow-up andor control visits
Visit 1
Physical examinationweight 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
Liver ultrasound
Ultrasound of abdominal and preperitoneal fat
Musculoskeletal ultrasound
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
Liver ultrasound
Ultrasound of abdominal and preperitoneal fat
Musculoskeletal ultrasound
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None