Clinical trial NCT03506581: Dysfunctional Adiposity and Glucose Impairment
Official title: Discovering Carbohydrate Metabolism Alterations in Normoglycemic Obese Patients Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Body Composition
Visceral Obesity
Carbohydrate Intolerance
Obesity, Abdominal
Cardiovascular Risk Factor
Beta-cell Function
Insulin Resistance
Oral Glucose Tolerance Test
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2018-04-24
Enrollment: 853
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Body fat percentage and carbohydrate intolerance
timeFrame: Baseline
measure: Neck circumference as screening tool
timeFrame: Baseline
Secondary outcomes:
measure: Waist-to-hip ratio as screening tool
timeFrame: Baseline
measure: Waist-to-height ratio as screening tool
timeFrame: Baseline
measure: BMI as screening tool
timeFrame: Baseline
measure: Body adiposity index as screening tool
timeFrame: Baseline
measure: Central fat depot and carbohydrate intolerance
timeFrame: Baseline
measure: Central fat depot and cardiometabolic risk
timeFrame: Baseline
measure: Body fat percentage and cardiometabolic risk
timeFrame: Baseline
measure: Prevalence of postprandial carbohydrate intolerance
timeFrame: Baseline
measure: Oral glucose tolerance test parameters and cardiometabolic profile
timeFrame: Baseline
measure: Non-alcoholic fatty liver disease (NAFLD) and glucose dysregulation
timeFrame: Baseline
measure: OGTT-based indices as screening tool of NAFLD
timeFrame: Baseline
measure: OGTT-derived glucose curve as screening tool of NAFLD
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Clínica Universidad de Navarra
name: Gema Frühbeck, PhD
role: STUDY_CHAIR
affiliation: Clínica Universidad de Navarra
name: Belén Pérez Pevida, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.