Inflammation and Glycation in a General Adult Population (AES)

This study is currently recruiting participants.
Verified June 2013 by Hospital Clinico Universitario de Santiago
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Francisco Gude, Hospital Clinico Universitario de Santiago
ClinicalTrials.gov Identifier:
NCT01796184
First received: February 14, 2013
Last updated: June 9, 2013
Last verified: June 2013
  Purpose

Background. Obesity, insulin resistance and type 2 diabetes are closely associated with chronic inflammation characterized by abnormal cytokine production. Some authors have found discordances between glycated hemoglobin (HbA1c) and other measures of glycemic control, suggesting that a "glycation gap", defined as the difference between the HbA1c concentration and that predicted by the fructosamine concentration, could explain the excess interindividual variation in HbA1c.

The present study was aimed to examine the association between inflammation, sociodemographic (age, gender) and lifestyle factors (diet, exercise, alcohol, and tobacco consumption), and common diseases. In addition, we also examine levels of blood glucose, HbA1c, fructosamine and "glycation gap" determining the prevalence of "high glycators" in a general adult population and their association with lifestyles and prevalent diseases.

Methods. Selection of a random sample of the general adult population from a single municipality (A-Estrada, Pontevedra, Spain), stratified by age. The initial sampling includes 3,500 subjects. Considering approximate 67% participation rate, the final study population would include more than 2,000 individuals. The standard workup includes structured questionnaires, skin prick test, periodontal examination, psychological tests, physical examination and blood determinations to allow for categorization of participants in terms of basic demographics, profession, education level, socioeconomic level, quality of life, physical activity, diet, alcohol consumption and smoking, atopy, obesity, diabetes, metabolic syndrome, hypertension, cardiovascular disease, and liver disease. We determine blood levels of inflammation markers, HBA1c, fructosamine and glucose. We will collect a urine sample for microalbuminuria determination. In addition, blood will be drawn to be stored at the Biobank of our Hospital. One half of participants (~1000 individuals) will undergo continuous glucose monitoring. The design is cross-sectional, followed by a longitudinal study using population registries for the determination of events (mortality).

Discussion. This comprehensive study in a general adult population provides an excellent opportunity to determine serum concentrations of inflammation and glycation markers and how they can vary widely with age, sex, common habits, metabolic abnormalities, and chronic diseases. The findings from this study should also help to find out the relationship between glucose profiles and HbA1c and fructosamine concentrations with diet and inflammation markers.

Keywords: Inflammation, glycation, glycated hemoglobin, glycation gap, continuous glucose monitoring, obesity, allergy, periodontal diseases, depression, metabolic diseases.


Condition
Inflammation

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Inflammation and Glycation in a General Adult Population

Further study details as provided by Hospital Clinico Universitario de Santiago:

Primary Outcome Measures:
  • Glycation gap levels [ Time Frame: At time of interview and after one week ] [ Designated as safety issue: No ]
    The glycation gap is calculated as the difference between measured HbA1c and predicted HbA1c from the fructosamine and glucose levels.

  • Interstitial glucose levels [ Time Frame: After one week ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood, serum


Estimated Enrollment: 1000
Study Start Date: November 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

This cross-sectional is being performed in the municipality of A-Estrada, in Northern Spain.

An age-stratified random sample of the population 18 years and older was drawm from the National Health System Registry

Criteria

Inclusion Criteria:

  • Female or male
  • 18 years and older
  • No evidence of acute illness, fever, undue stress

Exclusion Criteria:

  • Unable to give informed consent
  • Pregnant
  • Dementia
  • Terminal cancer
  • Allergy to adhesives
  • Any concomitant medical condition that would likely affect the evaluation of device performance
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01796184

Contacts
Contact: Manuela Alonso, PhD 0034981951774 manuela.alonso.sampedro@sergas.es

Locations
Spain
Centro de Saúde A-Estrada Recruiting
A Estrada, Pontevedra, Spain, 36680
Contact: Juan Sanchez-Castro, MD    0034986572063    juanjose.sanchez.castro@sergas.es   
Sub-Investigator: Jesus Rey-Garcia, MD         
Sub-Investigator: Carmen Fernandez-Merino, PhD, MD         
Sub-Investigator: Luis Meijide-Garcia, MD         
Principal Investigator: Juan Sanchez-Castro, MD         
Sponsors and Collaborators
Hospital Clinico Universitario de Santiago
Medtronic
Investigators
Study Chair: Arturo Gonzalez-Quintela, PhD, MD Hospital Clinico Universitario de Santiago
Study Chair: Francisco Gude, MD, PhD Hospital Clinico Universitario de Santiago
  More Information

No publications provided

Responsible Party: Francisco Gude, PhD, MD, Hospital Clinico Universitario de Santiago
ClinicalTrials.gov Identifier: NCT01796184     History of Changes
Other Study ID Numbers: FIS11/02219, Xunta de Galicia; ISCIII
Study First Received: February 14, 2013
Last Updated: June 9, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Clinico Universitario de Santiago:
Inflammation
Glycation
Continuous glucose monitoring
Adult population

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014