Dysfunctional Adiposity and Glucose Impairment (DICAMANO)

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.

Study Overview

• Status: Completed
• Conditions: Insulin Resistance; Body Composition; Cardiovascular Risk Factor; Obesity, Abdominal; Visceral Obesity; Carbohydrate Intolerance; Beta-cell Function; Oral Glucose Tolerance Test

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 853

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Fasting glucose level ≤ 5.5 mmol l-1
• BMI ≥ 25

Exclusion Criteria:

• Type 2 diabetes mellitus
• Severe renal, liver or thyroid dysfunction

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
Prevalence of postprandial carbohydrate intolerance	Assess the prevalence of postprandial carbohydrate intolerance in individuals with normal fasting glycaemia	Baseline
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
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
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
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

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Collaborators: Instituto de Salud Carlos III
• Investigators: Study Chair: Gema Frühbeck, PhD, Clinica Universidad de Navarra; Principal Investigator: Belén Pérez Pevida, MD, Clinica Universidad de Navarra

Publications and helpful links

General Publications

• Perez-Pevida B, Nunez-Cordoba JM, Romero S, Miras AD, Ibanez P, Vila N, Margall MA, Silva C, Salvador J, Fruhbeck G, Escalada J. Discriminatory ability of anthropometric measurements of central fat distribution for prediction of post-prandial hyperglycaemia in patients with normal fasting glucose: the DICAMANO Study. J Transl Med. 2019 Feb 18;17(1):48. doi: 10.1186/s12967-019-1787-5.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2009
• Primary Completion (Actual): August 28, 2014
• Study Completion (Actual): January 28, 2016

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: April 23, 2018
• First Posted (Actual): April 24, 2018

Study Record Updates

• Last Update Posted (Actual): April 25, 2018
• Last Update Submitted That Met QC Criteria: April 24, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Hyperinsulinism; Obesity; Insulin Resistance; Obesity, Abdominal
• Other Study ID Numbers: 167/2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No