The Monocyte Subsets in Obese Patients With and Without Metabolic Syndrome

NCT ID: NCT03241394

Last Updated: 2017-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-25

Study Completion Date

2017-09-15

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Metabolic Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Lean

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

No interventions assigned to this group

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

No interventions assigned to this group

Obese without MS

Individuals with BMI ≥ 30.0 Kg/m2 but not MS

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ioannina

OTHER

Sponsor Role lead

Responsible Party

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Georgios A. Christou

Cardiologist, Postdoctoral researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital of Ioannina

Ioannina, , Greece

Site Status RECRUITING

Countries

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Greece

Facility Contacts

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Stelios Tigas, Prof.

Role: primary

0030 6978642944

References

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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.

Reference Type DERIVED
PMID: 30864887 (View on PubMed)

Other Identifiers

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802

Identifier Type: -

Identifier Source: org_study_id

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