ObesityNCT03241394
The Monocyte Subsets in Obese Patients With and Without Metabolic Syndrome
An observational study of Obesity and Metabolic Syndrome, run by University Hospital, Ioannina at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Metabolic Syndrome
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 25 Jul 2017to 15 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- -
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
University Hospital of Ioannina
Ioannina
Stelios Tigas, Prof., 0030 6978642944, stigas@cc.uoi.gr
About this study
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
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
- Medical subject headings
- Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Monocyte subsets
Absolute blood count of classical (Mon1A), intermediate (Mon2A) and nonclassical (Mon3A) monocyte subsets wil be measured by flow cytometry.
Measured: Baseline measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start25 Jul 2017
- Primary completion15 Sep 2017 (estimated)
- Study completion15 Sep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios A. Christou, University Hospital, Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241394
- Sponsor's protocol ID
- 802
- Status last verified
- Aug 2017
- First submitted
- 2 Aug 2017
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30864887
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03241394
- Acronym / sponsor ID
- 802
- Conditions
- Obesity, Metabolic Syndrome
- Keywords
- Monocyte subsets, Obesity, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, IoanninaUniversity, hospital or other
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 15 Sep 2017 (estimated)
- Study completion
- 15 Sep 2017 (estimated)
- First posted
- 7 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
- Derived from this study: PubMed 30864887Christou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Metabolic Syndrome, run by University Hospital, Ioannina at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monocyte subsets (time frame: Baseline measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03241394, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2017.