Trials / Completed

CompletedNCT03506581

Dysfunctional Adiposity and Glucose Impairment

Discovering Carbohydrate Metabolism Alterations in Normoglycemic Obese Patients Study

Status: Completed
Phase: —
Study type: Observational
Enrollment: 853 (actual)

Sponsor: Clinica Universidad de Navarra, Universidad de Navarra · Academic / Other
Sex: All
Age: 18 Years – 70 Years
Healthy volunteers: —

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.

Conditions

Timeline

Start date: 2009-01-29
Primary completion: 2014-08-28
Completion: 2016-01-28
First posted: 2018-04-24
Last updated: 2018-04-25

Source: ClinicalTrials.gov record NCT03506581. Inclusion in this directory is not an endorsement.