The Monocyte Subsets in Obese Patients With and Without Metabolic Syndrome

August 2, 2017 updated by: Georgios A. Christou, University Hospital, Ioannina

The Investigation of the Role of Inflammation in the Insulin Resistance Syndrome: The Monocyte Subsets in Obese Patients With and Without Metabolic Syndrome

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Ioánnina, Greece
        • Recruiting
        • University Hospital of Ioannina
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ioannina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2017

Primary Completion (Anticipated)

September 15, 2017

Study Completion (Anticipated)

September 15, 2017

Study Registration Dates

First Submitted

August 2, 2017

First Submitted That Met QC Criteria

August 2, 2017

First Posted (Actual)

August 7, 2017

Study Record Updates

Last Update Posted (Actual)

August 7, 2017

Last Update Submitted That Met QC Criteria

August 2, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 802

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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