Inflammation and Glycation in a General Adult Population (AES)

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.

Study Overview

• Status: Completed
• Conditions: Inflammation

• Study Type: Observational
• Enrollment (Actual): 1516

Contacts and Locations

Study Locations

• Spain
  • Pontevedra
    • A Estrada, Pontevedra, Spain, 36680
      • Centro de Saúde A-Estrada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycation gap levels	The glycation gap is calculated as the difference between measured HbA1c and predicted HbA1c from the fructosamine and glucose levels.	At time of interview and after one week

Secondary Outcome Measures

Outcome Measure	Time Frame
Interstitial glucose levels	6 days

Collaborators and Investigators

• Sponsor: Hospital Clinico Universitario de Santiago
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: February 14, 2013
• First Submitted That Met QC Criteria: February 19, 2013
• First Posted (Estimate): February 21, 2013

Study Record Updates

• Last Update Posted (Estimate): May 22, 2015
• Last Update Submitted That Met QC Criteria: May 21, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Inflammation; Continuous glucose monitoring; Glycation; Adult population
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: FIS11/02219; Xunta de Galicia; ISCIII (Other Grant/Funding Number: 10CSA918028PR; PI11/02219; RD12/0005/0007)