Effects of Atypical Antipsychotic and Valproate Combination Therapy on Glucose and Lipid Metabolism in Schizophrenia
NCT00552500
Body Composition, Glucose Metabolism Disorders
St Louis, Missouri, United States
View Trial DetailsNCT Number: NCT03506581
This is a large and comprehensively phenotyped cohort with fasting glycaemia where the predictive value of body composition and anthropometric measures of total and central fat distribution for postprandial carbohydrate intolerance are studied.
Looking for future studies?
Notify Me18 year–70 year
All sexes
Observational
Subjects aged 18-70 years, who attended the Department of Endocrinology and Nutrition of the Clínica Universidad de Navarra from 2009-2014 for a check-up were offered to participate in the DICAMANO study. 853 subjects agreed to take part. Only those individuals with a normal fasting glucose level (≤5.5 mmol l-1) were analysed. Subjects with T2DM or severe renal, liver or thyroid dysfunction were excluded. Participants were instructed to temporarily discontinue for 48 hours any medication known to affect glucose or lipid metabolism. On the day of the study visit, each subject had a complete routine clinical assessment to evaluate the presence of cardiovascular, respiratory, renal or endocrine disorders. All patients underwent a 75-g OGTT with a concomitant anthropometric study, blood pressure monitoring and lipid profile analyses. They were classified by glucose tolerance on the basis of blood glucose levels according to ADA diagnostic criteria for T2DM (2017). Carbohydrate intolerance was defined as a 2-hOGTT glucose level ≥7.8 mmol l-1 (mg dl-1). Body composition, visceral adipose tissue, anthropometry study, OGTT-based parameters and cardiovascular risk factors are measured.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
Investigate whether body fat percentage estimated by air-displacement plethysmography (Bod-Pod®, Life Measurements, Concord, CA, USA) predicts postprandial carbohydrate intolerance early on in the metabolic dysregulation process.
Body fat percentage (BF%) is calculated from body density by means of the Siri equation.
Time frame: Baseline
Examine the predictive value of neck circumference as screening tool for the selection of patients who are most likely to benefit from an oral glucose tolerance test (OGTT)
Time frame: Baseline
Examine the predictive value of waist-to-hip ratio as screening tool for the selection of patients who are most likely to benefit from an oral glucose tolerance test (OGTT). Waist-to-hip ratio was calculated as waist circumference divided by hip circumference. Waist circumference was measured at the midpoint between the iliac crest and the rib cage on the mid-axillary line, and hip circumference at the level of the greater trochanters was measured to the nearest millimetre using a flexible tape.
Time frame: Baseline
Examine the predictive value of waist-to-height ratio as screening tool for the selection of patients who are most likely to benefit from an oral glucose tolerance test (OGTT). Waist-to-height ratio was calculated as waist circumference divided by height.
Time frame: Baseline
Examine the predictive value of body adiposity index (BMI) as screening tool for the selection of patients who are most likely to benefit from an oral glucose tolerance test (OGTT). BMI was calculated as weight in kilograms divided by height in meters squared.
Time frame: Baseline
Examine the predictive value of body adiposity index (BAI) ([hip circumference/height1.5]-18) as screening tool for the selection of patients who are most likely to benefit from an oral glucose tolerance test (OGTT).
Time frame: Baseline
Investigate whether central fat depot predicts postprandial carbohydrate intolerance early on in the metabolic dysregulation process. Visceral and abdominal adiposity was quantified by the use of the abdominal bioelectrical impedance analysis device ViScan (Tanita AB-140, Tanita Corp., Tokyo, Japan).
Time frame: Baseline
Investigate whether a higher central fat depot is able to identify those individuals with higher inflammatory parameters (c-reactive protein, homocysteine and uric acid) and cardiovascular risk (higher rate of hypercholesterolemia, hypertension and/or obstructive sleep apnea).
Body fat percentage (BF%) is calculated from body density by means of the Siri equation.
Time frame: Baseline
Investigate whether a higher body fat percentage is able to identify those individuals with higher inflammatory parameters (c-reactive protein, homocysteine and uric acid) and cardiovascular risk (higher rate of hypercholesterolemia, hypertension and/or obstructive sleep apnea).
Body fat percentage (BF%) is calculated from body density by means of the Siri equation.
Time frame: Baseline
Assess the prevalence of postprandial carbohydrate intolerance in individuals with normal fasting glycaemia
Time frame: Baseline
Verification of the utility of the two-hour OGTT glucose value to select those individuals with higher cardiometabolic risk (higher rate of hypercholesterolemia, hypertension and/or obstructive sleep apnea).
Time frame: Baseline
Analyse the association between NAFLD and OGTT-based ß-cell function and insulin resistance in non-diabetic subjects.
Time frame: Baseline
Examine whether OGTT-based ß-cell function and insulin resistance indices could be used as screening tools for the selection of patients who are most likely to benefit from a NAFLD-study.
Time frame: Baseline
Examine whether the glucose response curve could be used as screening tool for the selection of patients who are most likely to benefit from a NAFLD-study.
Clinica Universidad de Navarra, Universidad de Navarra
Other
Discovering Carbohydrate Metabolism Alterations in Normoglycemic Obese Patients Study
Acronym: DICAMANO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00552500
Body Composition, Glucose Metabolism Disorders
St Louis, Missouri, United States
View Trial DetailsNCT00460135
Body Composition, Body Weight
Montreal, Quebec, Canada
View Trial DetailsNCT04966299
Blood Erythritol, Blood Xylitol
Basel, Canton of Basel-City, Switzerland
View Trial DetailsNCT05307367
Adipose Tissue, Atrophy
Copenhagen, DK, Denmark
View Trial Details