Working... Menu

The Monocyte Subsets in Obese Patients With and Without Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03241394
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : August 7, 2017
Information provided by (Responsible Party):
Georgios A. Christou, University Hospital, Ioannina

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.

Condition or disease
Obesity Metabolic Syndrome

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: The Investigation of the Role of Inflammation in the Insulin Resistance Syndrome: The Monocyte Subsets in Obese Patients With and Without Metabolic Syndrome
Actual Study Start Date : July 25, 2017
Estimated Primary Completion Date : September 15, 2017
Estimated Study Completion Date : September 15, 2017

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Monocyte subsets [ Time Frame: Baseline measurement ]
    Absolute blood count of classical (Mon1A), intermediate (Mon2A) and nonclassical (Mon3A) monocyte subsets wil be measured by flow cytometry.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Inclusion Criteria:

Exclusion Criteria:

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03241394

Layout table for location information
University Hospital of Ioannina Recruiting
Ioánnina, Greece
Contact: Stelios Tigas, Prof.    0030 6978642944   
Sponsors and Collaborators
University Hospital, Ioannina

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Georgios A. Christou, Cardiologist, Postdoctoral researcher, University Hospital, Ioannina Identifier: NCT03241394     History of Changes
Other Study ID Numbers: 802
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Georgios A. Christou, University Hospital, Ioannina:
Monocyte subsets
Metabolic Syndrome

Additional relevant MeSH terms:
Layout table for MeSH terms
Metabolic Syndrome
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases