Dysfunctional Adiposity and Glucose Impairment (DICAMANO)
24 de abril de 2018 actualizado por: Clinica Universidad de Navarra, Universidad de Navarra
Discovering Carbohydrate Metabolism Alterations in Normoglycemic Obese Patients Study
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.
Descripción general del estudio
Estado
Terminado
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Actual)
853
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
N/A
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
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
Descripción
Inclusion Criteria:
- Fasting glucose level ≤ 5.5 mmol l-1
- BMI ≥ 25
Exclusion Criteria:
- Type 2 diabetes mellitus
- Severe renal, liver or thyroid dysfunction
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Body fat percentage and carbohydrate intolerance
Periodo de tiempo: 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. |
Baseline
|
|
Neck circumference as screening tool
Periodo de tiempo: 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)
|
Baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Waist-to-hip ratio as screening tool
Periodo de tiempo: 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.
|
Baseline
|
|
Waist-to-height ratio as screening tool
Periodo de tiempo: 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.
|
Baseline
|
|
BMI as screening tool
Periodo de tiempo: 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.
|
Baseline
|
|
Body adiposity index as screening tool
Periodo de tiempo: 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).
|
Baseline
|
|
Central fat depot and carbohydrate intolerance
Periodo de tiempo: 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).
|
Baseline
|
|
Central fat depot and cardiometabolic risk
Periodo de tiempo: 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. |
Baseline
|
|
Body fat percentage and cardiometabolic risk
Periodo de tiempo: 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. |
Baseline
|
|
Prevalence of postprandial carbohydrate intolerance
Periodo de tiempo: Baseline
|
Assess the prevalence of postprandial carbohydrate intolerance in individuals with normal fasting glycaemia
|
Baseline
|
|
Oral glucose tolerance test parameters and cardiometabolic profile
Periodo de tiempo: 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).
|
Baseline
|
|
Non-alcoholic fatty liver disease (NAFLD) and glucose dysregulation
Periodo de tiempo: Baseline
|
Analyse the association between NAFLD and OGTT-based ß-cell function and insulin resistance in non-diabetic subjects.
|
Baseline
|
|
OGTT-based indices as screening tool of NAFLD
Periodo de tiempo: 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.
|
Baseline
|
|
OGTT-derived glucose curve as screening tool of NAFLD
Periodo de tiempo: 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.
|
Baseline
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Colaboradores
Investigadores
- Silla de estudio: Gema Frühbeck, PhD, Clinica Universidad de Navarra
- Investigador principal: Belén Pérez Pevida, MD, Clinica Universidad de Navarra
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
29 de enero de 2009
Finalización primaria (Actual)
28 de agosto de 2014
Finalización del estudio (Actual)
28 de enero de 2016
Fechas de registro del estudio
Enviado por primera vez
6 de febrero de 2018
Primero enviado que cumplió con los criterios de control de calidad
23 de abril de 2018
Publicado por primera vez (Actual)
24 de abril de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de abril de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
24 de abril de 2018
Última verificación
1 de febrero de 2018
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 167/2016
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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