Inflammation and Glycation in a General Adult Population (AES)

This study is currently recruiting participants. (see Contacts and Locations)
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

February 14, 2013
June 9, 2013
November 2012
December 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01796184 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Inflammation and Glycation in a General Adult Population
Inflammation and Glycation in a General Adult Population

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.

Not Provided
Observational
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

whole blood, serum

Probability Sample

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

Inflammation
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
June 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Manuela Alonso, PhD 0034981951774 manuela.alonso.sampedro@sergas.es
Spain
 
NCT01796184
FIS11/02219, Xunta de Galicia; ISCIII
No
Francisco Gude, Hospital Clinico Universitario de Santiago
Hospital Clinico Universitario de Santiago
Medtronic
Study Chair: Arturo Gonzalez-Quintela, PhD, MD Hospital Clinico Universitario de Santiago
Study Chair: Francisco Gude, MD, PhD Hospital Clinico Universitario de Santiago
Hospital Clinico Universitario de Santiago
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP