Dysfunctional Adiposity and Glucose Impairment

NCT03506581 | Completed

• 1 other identifier: 167/2016
• Study Type: observational
• Target: 853
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Waist-to-hip ratio as screening tool

  Baseline

• Waist-to-height ratio as screening tool

  Baseline

• BMI as screening tool

  Baseline

• Body adiposity index as screening tool

  Baseline

• Central fat depot and carbohydrate intolerance

  Baseline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• Instituto de Salud Carlos III: collaborator

Related Publications (1)

• 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.

  PMID: 30777085 DERIVED

MeSH Terms

Conditions

Obesity, Abdominal; Glucose-Galactose Malabsorption; Insulin Resistance

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Gema Frühbeck, PhD

  Clínica Universidad de Navarra

  STUDY CHAIR

• Belén Pérez Pevida, MD

  Clínica Universidad de Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: April 24, 2018
• Study Start: January 29, 2009
• Primary Completion: August 28, 2014
• Study Completion: January 28, 2016
• Last Updated: April 25, 2018

Record last verified: 2018-02