The Monocyte Subsets in Obese Patients With and Without Metabolic Syndrome

NCT03241394 | Unknown

• 1 other identifier: 802
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is associated with a chronic low-grade inflammation characterized by macrophage infiltration in adipose tissue that induces insulin resistance and the appearance of metabolic syndrome (MS). The aim of the study was the investigation of whether circulating monocyte subsets are differentially regulated in MS.

Conditions

Obesity; Metabolic Syndrome

Keywords

Monocyte subsets; Obesity; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Monocyte subsets

  Absolute blood count of classical (Mon1A), intermediate (Mon2A) and nonclassical (Mon3A) monocyte subsets wil be measured by flow cytometry.

  Baseline measurement

Study Arms (3)

Lean

Individuals with Body Mass Index (BMI) = 18.5 - 25.0 Kg/m2

Obese with MS

Individuals with BMI ≥ 30.0 Kg/m2 and metabolic syndrome (MS) MS was defined as the presence of three or more of the following criteria: 1) waist circumference ≥ 102 cm in men and ≥ 88 cm in women, 2) serum triglycerides ≥ 150 mg/dL, 3) high density lipoprotein-cholesterol (HDL-C) \< 40 mg/dl in men and \< 50 mg/dl in women, 4) systolic blood pressure (SBP) ≥ 130 mmHg or diastolic blood pressure (DBP) ≥ 85 mmHg or antihypertensive drug treatment, 5) fasting glucose ≥ 100 mg/dL

Obese without MS

Individuals with BMI ≥ 30.0 Kg/m2 but not MS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In the present study healthy lean volunteers and obese subjects were recruited. The obese patients attended the Endocrinology outpatient clinic of the University Hospital of Ioannina in Greece. The obese patients were either with metabolic syndrome (MS) or without MS.

You may not qualify if:

• Age less than 18 years old, pregnancy, breast feeding, kidney disease, liver disease, gastrointestinal disease, malignancy, any endocrine disorder or metabolic disease, other than obesity or type 2 diabetes mellitus (T2DM), alteration of body weight (BW) by up of 5% of the initial BW during the last 3 months, any state of stress or systemic inflammation and taking any of the following drugs, within 3 weeks prior to the start of the study: hypolipidemic agents, antidiabetics, drugs for weight loss, nonsteroidal antiinflammatory drugs, glucocorticoids.

Sponsors & Collaborators

• University Hospital, Ioannina: lead

Study Sites (1)

University Hospital of Ioannina

Ioannina, Greece

RECRUITING

Related Publications (1)

• Christou KA, Christou GA, Karamoutsios A, Vartholomatos G, Gartzonika K, Tsatsoulis A, Tigas S. Metabolically Healthy Obesity Is Characterized by a Proinflammatory Phenotype of Circulating Monocyte Subsets. Metab Syndr Relat Disord. 2019 Jun;17(5):259-265. doi: 10.1089/met.2018.0132. Epub 2019 Mar 13.

  PMID: 30864887 DERIVED

MeSH Terms

Conditions

Obesity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist, Postdoctoral researcher

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 7, 2017
• Study Start: July 25, 2017
• Primary Completion: September 15, 2017
• Study Completion: September 15, 2017
• Last Updated: August 7, 2017

Record last verified: 2017-08

Locations

GR (1)