Morbid ObesityNCT03559842
Sleeve-gastrectomy Efficacy in Morbid Obese Patient With a Focus on the Role of Inflammation
An observational study of Morbid Obesity, run by University Of Perugia at 1 site in Italy.
Trial summary
Despite the wide range of studies concerning the positive effects of bariatric surgery on metabolic state of morbid obese patient, it is necessary to further investigate the specific role of the "sleeve-gastrectomy" intervention, going not only to research results in terms of safety or efficacy on the treatment of… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 4 May 2017to 31 Dec 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Morbid obese patients with BMI ≥ 40 kg / m2 (or ≥ 35 kg / m2 with at least one comorbidity)
Who may be able to join
- BMI ≥ 40 kg / m2 (or ≥ 35 kg / m2 with at least one comorbidity), aged between 18 and 65 years.
Who cannot join
- renal or hepatic impairment
- heart failure (New York Heart Association - NYHA II-IV)
- secondary causes of obesity
- major psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Internal Medicine
Perugia, 06132
Graziana Lupattelli, Prof, 00390755784023, graziana.lupattelli@unipg.it
About this study
Official title: Sleeve-gastrectomy Efficacy in the Treatment of Metabolic and Vascular Dysfunction of Morbid Obese Patient With a Focus on the Role of Inflammation
Despite the wide range of studies concerning the positive effects of bariatric surgery on metabolic state of morbid obese patient, it is necessary to further investigate the specific role of the "sleeve-gastrectomy" intervention, going not only to research results in terms of safety or efficacy on the treatment of comorbidities, but also aimed to understand whether the improvement of metabolic and cardiovascular parameters is due to total weight loss or rather to visceral fat loss, and how much of this improvement is attributable to changes in inflammatory status. The primary endpoint of the study is to evaluate the effect of sleeve-gastrectomy on metabolic parameters (glyco-lipidic assessment, vitamins), bone-remodelling parameters (vitamin D, parathormone) and cardiovascular parameters (blood pressure, flow-mediated dilation, indexed left ventricular mass, inter-ventricular septum, carotid intima-media thickness) in a large obese population on the basis of total weight loss (TWL), variation of visceral fat area (VFA), variation of peri-renal fat thickness and insulin resistance index ("Homeostasis Model Assessment-insulin resistance" - HOMA). In addition the investigators set themselves the objective of assessing whether the presence of comorbidities (diabetes and hypertension) can influence the effects of the intervention on the above parameters, and whether the levels of the NETs and of adipokines such as chemerin in the pre- and post-intervention can correlate with the metabolic-vascular dysfunction, and play a role in its eventual improvement.
- Conditions
- Morbid Obesity
- Medical subject headings
- Obesity, Morbid
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 |
|---|---|---|
| Surgery patients | Obese patients undergoing laparoscopic sleeve gastrectomy | |
| Non-surgery patients | Obese patients not undergoing laparoscopic sleeve gastrectomy (delayed or refused proposed treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
flow-mediated dilation
ultrasound evaluation
Measured: One year
obesity-related cardiomyopathy
cardiac ultrasonography
Measured: One year
insulin resistance
HOMA index
Measured: One year
ectopic adiposity
ultrasound evaluation of visceral fat
Measured: One year
inflammation
high sensitivity C reactive protein, sclerostin, osteopontin, cathepsin K, IL-10
Measured: One year
blood pressure
systolic and diastolic blood pressure
Measured: One year
carotid intima-media thickness
ultrasound evaluation
Measured: One year
microcirculatory function
Laser-Doppler flowmetry
Measured: One year
aortic stiffness
tonometry
Measured: One year
cardiovascular assessment
anti-hypertensive therapy variation (number of drugs)
Measured: One year
dyslipidemia
total cholesterol, triglycerides, HDL, LDL
Measured: One year
liver function
Evaluation of "Non-alcoholic fatty liver disease" (NAFLD) fibrosis score according to the following formula:
-1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet (×109/l) - 0.66 × albumin (g/dl).
Cutoffs:
NAFLD Score < -1.455 = low grade fibrosis; NAFLD Score -1.455 - 0.675 = indeterminate score; NAFLD Score > 0.675 = high grade fibrosis.
Measured: One year
biliary acid and sterols assessment
laboratory analysis
Measured: One year
bone metabolism assessment
vitamin D, PTH
Measured: One year
nutritional assessment
sideremia, vitamin B12, folates
Measured: One year
adipose tissue quantification
bioimpedentiometry
Measured: One year
adipokines
chemerin, leptin and adiponectin plasmatic dosage
Measured: One year
NETs
"Neutrophil extracellular traps" dosage
Measured: One year
Secondary outcomes (2)
inflammatory bone remodeling markers
sclerostin, osteopontin, cathepsin K
Measured: One year
macrophages commitment markers
interleukin-10
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start4 May 2017
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid 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
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Of Perugia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Anastasia Ricci, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559842
- Sponsor's protocol ID
- 2017-15
- Status last verified
- Mar 2020
- First submitted
- 19 May 2018
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleeve-gastrectomy Efficacy in the Treatment of Metabolic and Vascular Dysfunction of Morbid Obese Patient With a Focus on the Role of Inflammation
- ClinicalTrials.gov ID
- NCT03559842
- Acronym / sponsor ID
- 2017-15
- Conditions
- Morbid Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Of PerugiaUniversity, hospital or other
- Study start
- 4 May 2017 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 Jun 2018 (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.
Despite the wide range of studies concerning the positive effects of bariatric surgery on metabolic state of morbid obese patient, it is necessary to further investigate the specific role of the "sleeve-gastrectomy" intervention, going not only to research results in terms of safety or efficacy on the treatment of comorbidities, but also aimed to understand whether the improvement of metabolic and cardiovascular parameters is due to total weight loss or rather to visceral fat loss, and how much of this improvement is attributable to changes in inflammatory status. The primary endpoint of the study is to evaluate the effect of sleeve-gastrectomy on metabolic parameters (glyco-lipidic assessment, vitamins), bone-remodelling parameters (vitamin D, parathormone) and cardiovascular parameters (blood pressure, flow-mediated dilation, indexed left ventricular mass, inter-ventricular septum, carotid intima-media thickness) in a large obese population on the basis of total weight loss (TWL), variation of visceral fat area (VFA), variation of peri-renal fat thickness and insulin resistance index ("Homeostasis Model Assessment-insulin resistance" - HOMA). In addition the investigators set themselves the objective of assessing whether the presence of comorbidities (diabetes and hypertension) can influence the effects of the intervention on the above parameters, and whether the levels of the NETs and of adipokines such as chemerin in the pre- and post-intervention can correlate with the metabolic-vascular dysfunction, and play a role in its eventual improvement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery patients | – | –Obese patients undergoing laparoscopic sleeve gastrectomy |
| Non-surgery patients | – | –Obese patients not undergoing laparoscopic sleeve gastrectomy (delayed or refused proposed treatment) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Morbid obese patients with BMI ≥ 40 kg / m2 (or ≥ 35 kg / m2 with at least one comorbidity)
Key inclusion criteria (1 listed)
- BMI ≥ 40 kg / m2 (or ≥ 35 kg / m2 with at least one comorbidity), aged between 18 and 65 years.
Key exclusion criteria (4 listed)
- renal or hepatic impairment
- heart failure (New York Heart Association - NYHA II-IV)
- secondary causes of obesity
- major psychiatric disorders
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
flow-mediated dilation
Time frame: One year
ultrasound evaluation
obesity-related cardiomyopathy
Time frame: One year
cardiac ultrasonography
insulin resistance
Time frame: One year
HOMA index
ectopic adiposity
Time frame: One year
ultrasound evaluation of visceral fat
inflammation
Time frame: One year
high sensitivity C reactive protein, sclerostin, osteopontin, cathepsin K, IL-10
blood pressure
Time frame: One year
systolic and diastolic blood pressure
carotid intima-media thickness
Time frame: One year
ultrasound evaluation
microcirculatory function
Time frame: One year
Laser-Doppler flowmetry
aortic stiffness
Time frame: One year
tonometry
cardiovascular assessment
Time frame: One year
anti-hypertensive therapy variation (number of drugs)
dyslipidemia
Time frame: One year
total cholesterol, triglycerides, HDL, LDL
liver function
Time frame: One year
Evaluation of "Non-alcoholic fatty liver disease" (NAFLD) fibrosis score according to the following formula: -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet (×109/l) - 0.66 × albumin (g/dl). Cutoffs: NAFLD Score < -1.455 = low grade fibrosis; NAFLD Score -1.455 - 0.675 = indeterminate score; NAFLD Score > 0.675 = high grade fibrosis.
biliary acid and sterols assessment
Time frame: One year
laboratory analysis
bone metabolism assessment
Time frame: One year
vitamin D, PTH
nutritional assessment
Time frame: One year
sideremia, vitamin B12, folates
adipose tissue quantification
Time frame: One year
bioimpedentiometry
adipokines
Time frame: One year
chemerin, leptin and adiponectin plasmatic dosage
NETs
Time frame: One year
"Neutrophil extracellular traps" dosage
2 secondary outcomes
inflammatory bone remodeling markers
Time frame: One year
macrophages commitment markers
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
Related trials for Morbid Obesity
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
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 Morbid Obesity, run by University Of Perugia 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 4 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 11 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Graziana Lupattelli, Prof (00390755784023, graziana.lupattelli@unipg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
flow-mediated dilation (time frame: One year). The study lists 18 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 11 Mar 2020.