Metabolic SyndromeCROPNCT03561987

Biomarkers Derived From Adipose Tissue Useful for Diagnosis and Prognosis of Cardiovascular Risk (CVR) in Obese Patient

An observational study of Metabolic Syndrome and Diabetes Mellitus, run by Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This study evaluates the relationship between the adipose tissue, as an active component, which can define metabolic phenotypes linked to cardiovascular risk modification post bariatric surgery. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Metabolic Syndrome, Diabetes Mellitus, Inflammatory Response
What is being tested?: Bariatric surgery
Type of treatment: Surgery or procedure
How many people: 70 participants
Where: No sites listed yet
Study dates: 6 Nov 2013to 15 Jan 2022
How long will I take part?: 9 Months
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Morbid obese patients candidates to bariatric surgery.

Who may be able to join

Above 18 years old.
Morbid obese patients candidates to bariatric surgery.

Who cannot join

Second bariatric surgery

About this study

Official title: Identification of Biomarkers Derived From Adipose Tissue With Potential Utility in the Diagnosis and Prognosis of Cardiovascular Risk of the Obese Patient.

This study evaluates the relationship between the adipose tissue, as an active component, which can define metabolic phenotypes linked to cardiovascular risk modification post bariatric surgery.

Read the detailed description

Bariatric surgery induces a significant reduction in co-morbidities associated with obesity, such as Diabetes mellitus, dyslipidemia, liver disease, arterial hypertension, obstructive apnea and cardiovascular risk. However this does not happen in all obese patients, even when there is a weight reduction.

It is known that the adipose tissue is actively involved in synthesis of cytokines and its role in metabolic phenotypes has been suggested. It is possible that the intrinsic mechanisms of adipose tissue participate in several benefits observed in morbidly obese patients who undergo to an anti-obesity surgery.

So this study explores the involvement of adipose tissue as an active component, which can define metabolic phenotypes linked to cardiovascular risk modification post bariatric surgery.

Conditions: Metabolic Syndrome, Diabetes Mellitus, Inflammatory Response
Being tested: Bariatric surgery
Keywords: ADIPOSE TISSUE, CARDIOVASCULAR, OBESE PATIENTS
Medical subject headings: Metabolic Syndrome, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bariatric surgeryProcedure or surgery
There are two components to the procedure. First, a small stomach pouch, approximately one ounce or 30 milliliters in volume, is created by dividing the top of the stomach from the rest of the stomach. Next, the first portion of the small intestine is divided, and the bottom end of the divided small intestine is brought up and connected to the newly created small stomach pouch. The procedure is completed by connecting the top portion of the divided small intestine to the small intestine further down so that the stomach acids and digestive enzymes from the bypassed stomach and first portion of small intestine will eventually mix with the food.

Study groups in NCT03561987
Study group	Role	What they receive
Obese patients and bariatric surgery		The investigators include men and women, over 18 years old, with morbid obesity and candidates for bariatric surgery, under the routine of the treating service, with signature of acceptance of your participation, by informed consent. The investigators exclude patients with medication with potential effect on adipose tissue or cardiovascular risk in the last month, also with severe infections in the last month or clinically unstable conditions. Patients are eliminated in the study if they dont have the desire to continue in the study, and if the samples or the information are insufficient for an adequate analysis. Receives: Procedure: Bariatric surgery
No obese patients and abdominal surgery		The investigators include men and women, over 18 years old, without obesity and candidates for abdominal surgery (hernioplasty, cholecystectomy, fundoplication), under the routine of the treating service, with signature of acceptance of your participation, by informed consent. The investigators exclude patients with medication with potential effect on adipose tissue or cardiovascular risk in the last month, also with severe infections in the last month or clinically unstable conditions. Patients are eliminated in the study if they dont have the desire to continue in the study, and if the samples or the information are insufficient for an adequate analysis. Receives: Procedure: Bariatric surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluate the association of the cardiovascular benefit of the obese patient after bariatric surgery with the basic mechanisms of adipose tissue (metabolic profile)
Evaluate the association of the cardiovascular benefit of the obese patient after bariatric surgery with the basic mechanisms of adipose tissue (metabolic profile)
Measured: 3 years

Secondary outcomes (2)

Correlation between serum concentration of pro-inflammatory biomarker and the reduction of subclinical endothelial disfunction.
measurements of carotid intima-media thickness (CIMT) in millimeter and Flow mediated dilatation (FMD) in percent in a basal time and see over time the reduction (if any) of those endothelial markers
Measured: 9 months
Determine the association of the cardiovascular prognosis modification (risk subgroups) with the basal metabolic profile.
After the 9 months follow up, the authors will correlated the pro-inflammatory cytokines, presence or absence of adipose proteins.
Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Nov 201315 Jan 2022

First posted19 Jun 2018
Study start6 Nov 2013
Primary completion1 Dec 2020 (estimated)
Study completion15 Jan 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metabolic SyndromeStudies 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: 70 participants (estimated)
Target duration: 9 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT03561987
Sponsor's protocol ID: 386.2013
Acronym: CROP
Status last verified: Jun 2018
First submitted: 8 Jun 2018
Last updated: 5 Jul 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Identification of Biomarkers Derived From Adipose Tissue With Potential Utility in the Diagnosis and Prognosis of Cardiovascular Risk of the Obese Patient.
ClinicalTrials.gov ID: NCT03561987
Acronym / sponsor ID: CROP / 386.2013
Conditions: Metabolic Syndrome, Diabetes Mellitus, Inflammatory Response
Keywords: ADIPOSE TISSUE, CARDIOVASCULAR, OBESE PATIENTS
Study type: Observational
Recruitment status: Unknown status
Enrolment: 70 participants (estimated)
Lead sponsor: Instituto de Seguridad y Servicios Sociales de los Trabajadores del EstadoOther government
Study start: 6 Nov 2013 (actual)
Primary completion: 1 Dec 2020 (estimated)
Study completion: 15 Jan 2022 (estimated)
First posted: 19 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.

This study evaluates the relationship between the adipose tissue, as an active component, which can define metabolic phenotypes linked to cardiovascular risk modification post bariatric surgery.

Detailed description

So this study explores the involvement of adipose tissue as an active component, which can define metabolic phenotypes linked to cardiovascular risk modification post bariatric surgery.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 9 Months
Number of arms: 2

Arm	Type	Receives
Obese patients and bariatric surgery	–	Procedure: Bariatric surgeryThe investigators include men and women, over 18 years old, with morbid obesity and candidates for bariatric surgery, under the routine of the treating service, with signature of acceptance of your participation, by informed consent. The investigators exclude patients with medication with potential effect on adipose tissue or cardiovascular risk in the last month, also with severe infections in the last month or clinically unstable conditions. Patients are eliminated in the study if they dont have the desire to continue in the study, and if the samples or the information are insufficient for an adequate analysis.
No obese patients and abdominal surgery	–	Procedure: Bariatric surgeryThe investigators include men and women, over 18 years old, without obesity and candidates for abdominal surgery (hernioplasty, cholecystectomy, fundoplication), under the routine of the treating service, with signature of acceptance of your participation, by informed consent. The investigators exclude patients with medication with potential effect on adipose tissue or cardiovascular risk in the last month, also with severe infections in the last month or clinically unstable conditions. Patients are eliminated in the study if they dont have the desire to continue in the study, and if the samples or the information are insufficient for an adequate analysis.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Morbid obese patients candidates to bariatric surgery.

Key inclusion criteria (2 listed)

Above 18 years old.
Morbid obese patients candidates to bariatric surgery.

Key exclusion criteria (1 listed)

Second bariatric surgery

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
Bariatric surgeryThere are two components to the procedure. First, a small stomach pouch, approximately one ounce or 30 milliliters in volume, is created by dividing the top of the stomach from the rest of the stomach. Next, the first portion of the small intestine is divided, and the bottom end of the divided small intestine is brought up and connected to the newly created small stomach pouch. The procedure is completed by connecting the top portion of the divided small intestine to the small intestine further down so that the stomach acids and digestive enzymes from the bypassed stomach and first portion of small intestine will eventually mix with the food.	Procedure or surgery	No obese patients and abdominal surgery, Obese patients and bariatric surgery

Primary outcome

Evaluate the association of the cardiovascular benefit of the obese patient after bariatric surgery with the basic mechanisms of adipose tissue (metabolic profile)
Time frame: 3 years
Evaluate the association of the cardiovascular benefit of the obese patient after bariatric surgery with the basic mechanisms of adipose tissue (metabolic profile)

2 secondary outcomes

Correlation between serum concentration of pro-inflammatory biomarker and the reduction of subclinical endothelial disfunction.
Time frame: 9 months
Determine the association of the cardiovascular prognosis modification (risk subgroups) with the basal metabolic profile.
Time frame: 9 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
Individual participant dataSharing planned: Undecided

Related trials for Metabolic Syndrome

RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy

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.

Questions about this trial

What is this clinical trial studying?

An observational study of Metabolic Syndrome and Diabetes Mellitus, run by Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado.

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 2 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 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

Evaluate the association of the cardiovascular benefit of the obese patient after bariatric surgery with the basic mechanisms of adipose tissue (metabolic profile) (time frame: 3 years). 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 NCT03561987.

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 5 Jul 2018.