Infusion of 3% sodium chloride for osmotic stimulation of vasopressin

Infusion of 0.9% sodium chloride that will induce similar expansion of plasma volume without any significant change in osmolality and vasopressin

Insulin Resistance

0.1 ml of 3% NaCl per kg of body weight per minute

Hypertonic Saline (3% NaCl)

0.1 ml of 0.9% NaCl per kg of body weight per minute

Isotonic Saline (0.9% NaCl)

University of Arkansas

The Effect of Vasopressin on Glucose Regulation

The Effect of Osmotically Stimulated Vasopressin on Glucose Regulation

the area under the glucose curve (AUC) in mg/dL x min

the area under the insulin curve (AUC) in microU/mL x min

the response of thirst and mouth dryness will be scored in mm via a visual analog scale of 125mm length.

Energy expenditure calculated via indirect calorimetry in kcal/min

g of carbohydrates and fat oxidized based on the amount of oxygen consumed and carbon dioxide produced assessed by indirect calorimetry

Stavros Kavouras

Associate Professor

University of Arkansas, Fayetteville

Danone Research

paliperidone ER 6-mg or 9-mg tablet once daily flexible dosing for 6 months

olanzapine 10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months

6-mg or 9-mg tablet once daily flexible dosing for 6 months

Paliperidone ER

10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months

Olanzapine

Total

Sex: Female, Male

Body Mass Index (BMI)

Waist

Weight

Plasma fasting TG and HDL concentrations were measured to determine the TG:HDL ratio.

Change From Baseline to End Point in the Triglycerides (TG) to High Density Lipoprotein (HDL) Ratio (TG:HDL Ratio)

The TG level was assessed under fasted conditions.

Change From Baseline to End Point in Triglycerides

The HDL level was assessed under fasted conditions.

Change From Baseline to End Point in High Density Lipoprotein

The total cholesterol level was assessed under fasted conditions.

Change From Baseline to End Point in Total Cholesterol

The level of low density lipoprotein cholesterol was calculated using the Friedwald QT formula.

Change From Baseline to End Point in Low Density Lipoprotein Cholesterol (Friedwald QT)

The insulin level was assessed under fasted conditions.

Change From Baseline to End Point in Converted Insulin

Change From Baseline to End Point in Fasting Glucose

HOMA-%B is used to assess beta-cell function. HOMA-%B is a dimensionless measure of beta-cell function (higher values present increased insulin secretion for a given glucose level).
HOMA-%B is normalized so that lean, healthy individuals will have values of HOMA-%B close to 100%.

Change From Baseline to End Point in Homeostatic Model Assessment of Beta-cell Function (HOMA-%B)

HOMA-IR is used to assess insulin resistance (IR). HOMA-IR is a dimensionless measure of insulin resistance (higher values present more insulin resistance. HOMA-IR are normalized so that lean, healthy individuals will have values of HOMA-IR close to 1.

Change From Baseline to End Point in Homeastatic Model Assessment of Insulin Resistance (HOMA-IR)

Fasting plasma glucose ≥126 mg/dL or 2-hour post-load plasma glucose ≥200 mg/dL during an oral glucose tolerance test (OGTT) or initiated use of glucose-lowering agents during the course of the study.

Number of Patients Meeting the Criteria for Type 2 Diabetes Mellitus During Follow-up

Glucose ≥140 mg/dL, <200 mg/dL after a 75g OGTT.

Number of Patients With Onset of Impaired Glucose Tolerance

Post-baseline glucose level under fasted conditions ≥100 mg/dL but <126 mg/dL.

Number of Patients With Impaired Fasting Glucose

The insulinogenic index, defined as (insulin at 30 min - insulin at 0)/(glucose at 30 min [G(30)] - glucose at 0 [G(0)]) was used as a measure of early insulin secretion in response to the OGTT. Because the index is undefined when G(30)-G(0)=0, and poorly defined when G(30)-G(0)<0, the index was only calculated when G(30)>G(0).

Change From Baseline at End Point of the Insulinogenic Index

As another measure of beta-cell function, the relationship between plasma insulin and glucose concentrations during the OGTT was calculated using a simplified version of the method described by Mari et al. (Mari A, Sallas WM, He YL, Watson C, Ligueros-Saylan M, Dunning BE, Deacon CF, Holst JJ, Foley JE. Vildagliptin, a dipeptidyl peptidase-IV inhibitor, improves model-assessed beta-cell function in patients with type 2 diabetes. J Clin Endocrinol Metab. 2005; 90:4888-4894.).

Change From Baseline at End Point of Mari-Type Analysis of Glucose Sensitivity for Insulin

Patients were weighed lightly clothed. The same amount of clothing had to be worn each time.

Change From Baseline at End Point in Body Weight

BMI is calculated by dividing the body weight (in kg) by the square of height (in meters).

Change From Baseline at End Point in Body Mass Index (BMI)

Patients had to be instructed to stand erect with abdomen relaxed, arms at sides, feet together, and weight divided equally over both legs. The tape measure was placed around the bare abdomen midway between the palpated iliac crest and the palpated lowest rib margin in the left and right mid-axillary lines. A nonstretchable tape was evenly placed around the natural waist covering the left and right natural-waist marks. The measurement scale had to face outward, and there could not be any twists in the tape. The tape had to be just touching the skin but not compressing the soft tissue.

Change From Baseline at End Point in Waist Circumference

Metabolic syndrome is defined according the Third Report of the National Cholesterol Education Program Expert Panel on
Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (NCEP/ATPIII) of which 3 out of 5 criteria must be met:
waist circumference men > 102 cm; waist circumference women > 88 cm
TG ≥ 150 mg/dL
HDL cholesterol men <40 mg/dL; HDL cholesterol women <50 mg/dL
Blood pressure systolic ≥ 130 mmHg; Blood pressure diastolic ≥ 85 mmHg
Fasting glucose ≥ 110 mg /dL

Number of Patients First Meeting the NCEP/ATP III Criteria for Metabolic Syndrome During Follow-up

PANSS is an investigator-rated 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The PANSS provided a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme).

Change From Baseline to End Point in Total Positive and Negative Syndrome Scale Score (PANSS)

Paliperidone Extended Release (ER)

Overall Study

EMEA Therapeutic Area Leader CNS

Schizophrenia

olanzapine

paliperidone ER

A Prospective Randomized Open-label 6-Month Head-To-Head Trial to Compare Metabolic Effects of Paliperidone ER and Olanzapine in Subjects With Schizophrenia

A 6 Month Study to Compare the Metabolic Effects of Paliperidone ER and Olanzapine in Patients With Schizophrenia

Janssen-Cilag International NV

Oral (tablets), 16-24 mg QD (once a day) for 12 weeks.

Sertindole

Oral (tablets), 4-8 mg QD (once a day) for 12 weeks.

Risperidone

Department of Psychiatry of the Sheba Medical Center

Beer-Yaakov Mental Health Center

Kfar Shaul Mental Health Center

Comparison of Cognitive Functions of Schizophrenic Patients Treated With Sertindole Versus Risperidone

Prof. Mark Weiser

Sheba Medical Center

Bipolar Disorder

Schizoaffective Disorder

Lithium

Chlorpromazine

ORYGEN Youth Health

Comparison of Combination Olanzapine+Lithium or Chlorpromazine+Lithium in Treatment of First Manic Episode With Psychotic Features

Comparison of Combination Olanzapine and Lithium and Combination Chlorpromazine and Lithium in the Treatment of a First Manic Episode With Psychotic Features.

xerostomia/triglyceride

The Effect of Vasopressin on Glucose Regulation

A 6 Month Study to Compare the Metabolic Effects of Paliperidone ER and Olanzapine in Patients With Schizophrenia

Comparison of Cognitive Functions of Schizophrenic Patients Treated With Sertindole Versus Risperidone

Comparison of Combination Olanzapine+Lithium or Chlorpromazine+Lithium in Treatment of First Manic Episode With Psychotic Features

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