Dysfunctional Adiposity and Glucose Impairment

Insulin Resistance Clinical Trial

— DICAMANO  

Official title:

Discovering Carbohydrate Metabolism Alterations in Normoglycemic Obese Patients Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03506581
• Other study ID #: 167/2016
• Status: Completed
• First received: February 6, 2018
• Last updated: April 24, 2018
• Start date: January 29, 2009
• Est. completion date: January 28, 2016

Study information

• Verified date: February 2018
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 853
• Est. completion date: January 28, 2016
• Est. primary completion date: August 28, 2014
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Fasting glucose level = 5.5 mmol l-1

• BMI = 25

Exclusion Criteria:

• Type 2 diabetes mellitus

• Severe renal, liver or thyroid dysfunction

Related Conditions & MeSH terms

• Beta-cell Function
• Body Composition
• Carbohydrate Intolerance
• Carbohydrate Metabolism, Inborn Errors
• Cardiovascular Risk Factor
• Insulin Resistance
• Malabsorption Syndromes
• Obesity
• Obesity, Abdominal
• Oral Glucose Tolerance Test
• Visceral Obesity

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra	Instituto de Salud Carlos III

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body fat percentage and carbohydrate intolerance	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
Primary	Neck circumference as screening tool	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
Secondary	Waist-to-hip ratio as screening tool	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
Secondary	Waist-to-height ratio as screening tool	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
Secondary	BMI as screening tool	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
Secondary	Body adiposity index as screening tool	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
Secondary	Central fat depot and carbohydrate intolerance	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
Secondary	Central fat depot and cardiometabolic risk	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
Secondary	Body fat percentage and cardiometabolic risk	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
Secondary	Prevalence of postprandial carbohydrate intolerance	Assess the prevalence of postprandial carbohydrate intolerance in individuals with normal fasting glycaemia	Baseline
Secondary	Oral glucose tolerance test parameters and cardiometabolic profile	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
Secondary	Non-alcoholic fatty liver disease (NAFLD) and glucose dysregulation	Analyse the association between NAFLD and OGTT-based ß-cell function and insulin resistance in non-diabetic subjects.	Baseline
Secondary	OGTT-based indices as screening tool of NAFLD	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
Secondary	OGTT-derived glucose curve as screening tool of NAFLD	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