Inflammation and Glycation in a General Adult Population

NCT01796184 | Completed

• 2 other identifiers: FIS11/02219Xunta de Galicia; ISCIII
• Study Type: observational
• Target: 1,516
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammation

Keywords

Inflammation; Glycation; Continuous glucose monitoring; Adult population

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Interstitial glucose levels

  6 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinico Universitario de Santiago: lead
• Medtronic: collaborator

Study Sites (1)

Centro de Saúde A-Estrada

A Estrada, Pontevedra, 36680, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arturo Gonzalez-Quintela, PhD, MD

  Hospital Clinico Universitario de Santiago

  STUDY CHAIR

• Francisco Gude, MD, PhD

  Hospital Clinico Universitario de Santiago

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: February 21, 2013
• Study Start: November 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 22, 2015

Record last verified: 2015-05

Locations

ES (1)