ObesityNCT04318288
Comparison of Anthropometric Parameters and Cardiometabolic Risk Factors Among Subjects With Overweight and Obesity
An observational study of Obesity, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
Trial summary
The study was aimed at comparing four different anthropometric parameters to cardiometabolic risk factors in overweight and obese subjects (Body Mass Index (BMI)≥25) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obesity
- What is being tested?
- Observational
- How many people
- 1,214 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2019to 20 Dec 2019
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients who came to the Outpatient Clinic of Nutrition at the National Institute of Gastroenterology "S. de Bellis," Research Hospital, Castellana Grotte, Italy.
Who may be able to join
- Overweight or obesity (BMI> 25 Kg/m2)
Who cannot join
- Any kind of drug
- Hypertension
- Endocrine diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.),
- Chronic inflammatory diseases
- Renal failure
- Liver failure
Show all 10Show fewer
- Angina pectoris
- Myocardial infarction and heart failure
- Genetic heart diseases
- Thrombocytopenias
Trial locations and contacts
1 site in 1 country.
Italy1 site
National Institute of Gastroenterology IRCCS S. de Bellis
Castellana Grotte, Bari, 70013
About this study
Official title: Comparison of Different Anthropometric Parameters in Relation to Cardiometabolic Risk Factors in a Cohort of Subjects With Overweight and Obesity
The study was aimed at comparing four different anthropometric parameters to cardiometabolic risk factors in overweight and obese subjects (Body Mass Index (BMI)≥25)
Read the detailed description
the present study was focused to compare the level of statistical association among four different anthropometric parameters, body mass index (BMI), waist circumference (WC), waist to height ratio (WHtR) and neck circumference (NC) and the cardiovascular (CV) risk factors most commonly evaluated in the clinical practice such as systolic and diastolic blood pressure, and fasting glucose, lipid (triglycerides, total, High-density lipoprotein (HDL) and Low-density lipoprotein (LDL) cholesterol), insulin, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), uric acid, 25-hydroxyvitamin D (25(OH)D), c-reactive protein (CRP), white blood cells and platelet number in a population of 1214 apparently healthy subjects with overweight and obesity subjects
- Conditions
- Obesity
- Being tested
- Observational
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
Body mass index (BMI) (expressed in kg/m^2)
Measured: baseline
waist circumference
waist circumference (WC) (expressed in cm)
Measured: baseline
neck circumference
neck circumference (NC) (expressed in cm)
Measured: baseline
waist to height ratio
waist to height ratio (WHtR)
Measured: baseline
Secondary outcomes (13)
Intima-media thickness
Intima-media thickness (IMT) (expressed in mm)
Measured: baseline
Blood pressure
blood pressure (BP) expressed in mmHg
Measured: baseline
Total Cholesterol
Total Cholesterol (expressed in mg/dL) concentration in serum
Measured: baseline
Triglyceride
Triglyceride (expressed in mg/dL) concentration in serum
Measured: baseline
fasting blood glucose
fasting blood glucose (FBG) (expressed in mg/dL) concentration in serum
Measured: baseline
HDL Cholesterol
HDL Cholesterol (expressed in mg/dL) concentration in serum
Measured: baseline
Insulin
Insulin (expressed in mg/dL) concentration in serum
Measured: baseline
Homeostasis model assessment: insulin resistance
Homeostasis model assessment: insulin resistance index (HOMA-IR)
Measured: baseline
LDL Cholesterol
LDL Cholesterol (expressed in mg/dL) concentration in serum
Measured: baseline
Platelets
Platelets (expressed in 10^3/µL) concentration in serum
Measured: baseline
white blood cells
white blood cells (WBC) (expressed in 10^3/µL) concentration in serum
Measured: baseline
Vitamin D
Vitamin D (expressed in ng/dL) concentration in serum
Measured: baseline
C-reactive Protein
C-reactive Protein (CRP) (expressed in mg/dL)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start7 Jan 2019
- Primary completion30 Nov 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluigi Giannelli, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318288
- Sponsor's protocol ID
- 2/2020
- Status last verified
- Mar 2020
- First submitted
- 20 Mar 2020
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Anthropometric Parameters in Relation to Cardiometabolic Risk Factors in a Cohort of Subjects With Overweight and Obesity
- ClinicalTrials.gov ID
- NCT04318288
- Acronym / sponsor ID
- 2/2020
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,214 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 23 Mar 2020 (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.
The study was aimed at comparing four different anthropometric parameters to cardiometabolic risk factors in overweight and obese subjects (Body Mass Index (BMI)≥25)
Detailed description
the present study was focused to compare the level of statistical association among four different anthropometric parameters, body mass index (BMI), waist circumference (WC), waist to height ratio (WHtR) and neck circumference (NC) and the cardiovascular (CV) risk factors most commonly evaluated in the clinical practice such as systolic and diastolic blood pressure, and fasting glucose, lipid (triglycerides, total, High-density lipoprotein (HDL) and Low-density lipoprotein (LDL) cholesterol), insulin, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), uric acid, 25-hydroxyvitamin D (25(OH)D), c-reactive protein (CRP), white blood cells and platelet number in a population of 1214 apparently healthy subjects with overweight and obesity subjects
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who came to the Outpatient Clinic of Nutrition at the National Institute of Gastroenterology "S. de Bellis," Research Hospital, Castellana Grotte, Italy.
Key inclusion criteria (1 listed)
- Overweight or obesity (BMI> 25 Kg/m2)
Key exclusion criteria (10 listed)
- Any kind of drug
- Hypertension
- Endocrine diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.),
- Chronic inflammatory diseases
- Renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalObservational | Other | – |
Primary outcome
Body mass index
Time frame: baseline
Body mass index (BMI) (expressed in kg/m^2)
waist circumference
Time frame: baseline
waist circumference (WC) (expressed in cm)
neck circumference
Time frame: baseline
neck circumference (NC) (expressed in cm)
waist to height ratio
Time frame: baseline
waist to height ratio (WHtR)
13 secondary outcomes
Intima-media thickness
Time frame: baseline
Blood pressure
Time frame: baseline
Total Cholesterol
Time frame: baseline
Triglyceride
Time frame: baseline
fasting blood glucose
Time frame: baseline
HDL Cholesterol
Time frame: baseline
Insulin
Time frame: baseline
Homeostasis model assessment: insulin resistance
Time frame: baseline
LDL Cholesterol
Time frame: baseline
Platelets
Time frame: baseline
white blood cells
Time frame: baseline
Vitamin D
Time frame: baseline
C-reactive Protein
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
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 10 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: finished, as of the sponsor's last update on 24 Mar 2020. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2020.