s100β, neuron specific enolase and glial fibrillary acidic

Donor Site Complication

Delirium

Uremic Encephalopathy

Neurologic Manifestations

On living donor hepatectomy (preoperative), the first following day of surgery, 3rd day, and 7th day, blood will be taken for the measurement of S100β, NSE, and GFAP levels in the postoperative period. The plasma of the blood taken will be separated and stored at -800C. Values will be measured by the ELISA method. During the hospitalization, the delirium status of the patients will be evaluated with the delirium evaluation scale (Delirium Rating Scale-Revised - 98 Turkish version). Functional and cognitive information and other results will be collected at each follow-up point.

Living Donor Hepatectomy

Akdeniz University Medical Faculty Department of Anesthesiology and Reanimation

s100β, NSE n GFAP in Living Donor Hepatectomy and Delirium

In Living Donor Hepatectomy Cases, the Preoperative and Postoperative Relationship Between s100β, NSE and GFAP Levels and Postoperative Delirium

Approximately 25 patients planned to have living donor hepatectomy will be included in the study. The blood samples are taken in the preoperative period before the induction of anesthesia in the operating room and postoperative (the first day, the third day and the seventh day) period to analyze S100β serum concentrations and neurologic damage of living donor hepatectomy patients besides evaluating its effect on prognosis. These samples shall be kept at -80 0C until the plasma separation process.

Approximately 25 patients planned to have living donor hepatectomy will be included in the study. The blood samples are taken in the preoperative period before the induction of anesthesia in the operating room and postoperative (the first day, the third day and the seventh day) period to analyze NSE serum concentrations and neurologic damage of living donor hepatectomy patients besides evaluating its effect on prognosis. These samples shall be kept at -80 0C until the plasma separation process.

Approximately 25 patients planned to have living donor hepatectomy will be included in the study. The blood samples are taken in the preoperative period before the induction of anesthesia in the operating room and postoperative (the first day, the third day and the seventh day) period to analyze GFAP serum concentrations and neurologic damage of living donor hepatectomy patients besides evaluating its effect on prognosis. These samples shall be kept at -80 0C until the plasma separation process.

During the hospitalization, the delirium status of the patients will be evaluated with the delirium evaluation scale (Delirium Rating Scale-Revised - 98 Turkish version). Functional and cognitive information and other results will be collected at each follow-up point.

Bora Dinc

MD. Assist. Prof.

Akdeniz University

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Placebo

Placebo

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Fenofibrate

Fenofibrate Monotherapy

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Wax Matrix Extended Release Niacin (WMER Niacin)

WMER Niacin Monotherapy

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Fenofibrate
Wax Matrix Extended Release Niacin (WMER Niacin)

Combination Therapy

Total

Sex: Female, Male

Weight (in Kilograms) and Height (in Meters) were measured using a portable stadiometer with movable head piece typically mounted on balanced beam scale (Segma, Germany). Body mass index (BMI) is the relative weight for height and it was calculated according to formula bellow:
BMI=Weight (Kg) / Height2 (m)

Body Mass Index (BMI)

Assessments involve the measurement of serum Triglyceride (TG) level.

Changes Serum Triglyceride Levels

Assessments involve the measurement of serum Total (TC), High density lipoprotein (HDL-C) and direct Low density lipoprotein (d-LDL-C) cholesterol levels.
Serum non HDL-C levels is calculated by subtracting HDL-C from TC. Serum Remnant cholesterol (RC) is calculated by subtracting HDL-C and d-LDL-C from TC.

Changes in Serum Lipoprotein Cholesterol Levels

Assessments involve the measurement of serum Apolipoprotein A1 (Apo A1) and B (Apo B) levels.

Changes in Serum Apolipoprotein Levels

Assessments involve the measurement of serum fasting glucose levels.

Changes in Serum Fasting Glucose Levels.

Assessments involve the measurement of serum creatinine which is used to calculate eGFR using the CKD-EPI equation (2009) .

Changes in Estimated Glomerular Filtration Rate (eGFR)

Assessments involve the measurement of serum uric acid levels

Changes in Serum Uric Acid Levels

Assessments involve the measurement of serum enzymes including Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) levels.

Changes in Serum Enzymes Levels

Assessments involve the measurement of systolic and diastolic blood pressure. Patients were allowed to rest for 15 minutes in sitting position, and Walgreens Homedics WGNBPA-540 upper arm blood pressure monitor (Walgreens, China), was used for the measurement of blood pressure. Three consecutive readings were taken at 1 minute interval, and systolic and diastolic blood pressure were calculated as the mean of the last two readings.

Changes in Systolic and Diastolic Blood Pressure

Assessments comprise the total number of participants complicating and reporting muscle pain,flushing, nausea, vomiting, and dizziness.
As part of the complete safety profile of each arm,other specific reported adverse event are presented in the Adverse Event Module.

Adverse Events

Overall Study

Lewai Sharki Abdulaziz

Atherogenic Dyslipidemia

Obesity Associated Disorder

Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Therapeutic Lifestyle Changes

Fenofibrate

Wax Matrix Extended Release Niacin (WMER Niacin)

Al Kindy College of Medicine, University of Baghdad

Lewai S Abdulaziz

Extended Release Niacin and Fenofibrate for the Treatment of Atherogenic Dyslipidemia in Obese Females

Efficacy and Safety of Extended Release Niacin-Fenofibrate Combination and Monotherapy for the Treatment of Atherogenic Dyslipidemia in Obese Females

Individual participant data that underlie the results reported in this article, after deidentification (table, figures, and appendices).

Lewai Sharki Abdulaziz, MSc PhD

Assistant Professor

Al-Kindy College of Medicine

All subjects are expected to have the same interventions- Niacin and Endotoxin.

Immediate Release Niacin, Extended Release Niacin, Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).

Niacin and Endotoxin

Race (NIH/OMB)

Niacin/Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).

Niacin/Endotoxin

Baseline and Peak TNF-alpha Values as Categorized by Race and Gender

Baseline and Peak C-Reactive Protein (CRP) Values as Categorized by Race and Gender

Muredach Reilly

Healthy Volunteers

Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).

Immediate Release Niacin, Extended Release Niacin, Endotoxin

University of Pennsylvania

The Genetics of Evoked Responses to Niacin and Endotoxemia: The GENE Study

Hypercholesterolemia

3,5-Diiodothyropropionic acid (DITPA) therapy

Johns Hopkins Bayview Medical Center

Study of 3,5-Diiodothyropropionic Acid (DITPA) in Hypercholesterolemic Patients

A Randomized, Double-Blind Placebo-Controlled Study of 3,5-diiodothyropropionic Acid (DITPA) in Combination With Standard Therapy to Attain NCEP ATP III Goal for LDL Cholesterol in Hypercholesterolemic Patients

niacin/fever

s100β, NSE n GFAP in Living Donor Hepatectomy and Delirium

Extended Release Niacin and Fenofibrate for the Treatment of Atherogenic Dyslipidemia in Obese Females

The Genetics of Evoked Responses to Niacin and Endotoxemia: The GENE Study

Study of 3,5-Diiodothyropropionic Acid (DITPA) in Hypercholesterolemic Patients

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