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Status unknownNCT03561987CROPUpdated Jul 5, 2018

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

An observational study in Metabolic Syndrome, Diabetes Mellitus and Inflammatory Response, sponsored by Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-05.

Sponsored by Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado · Observational

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Metabolic Syndrome
  • Diabetes Mellitus
  • Inflammatory Response

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Keywords

  • ADIPOSE TISSUE, CARDIOVASCULAR, OBESE PATIENTS
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In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's planned enrollment of 70 is below the median of 200 across 458 observational studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Morbid obese patients candidates to bariatric surgery.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Second bariatric surgery
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
70 participants (estimated)
Target follow-up
9 Months
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

    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.

    Procedure: Bariatric surgery

Interventions

  • ProcedureBariatric 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.

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What researchers measure

Primary outcomes

  1. 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)

    Time frame: 3 years

Secondary outcomes

  1. 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

    Time frame: 9 months

  2. 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.

    Time frame: 9 months

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Study locations

No study locations are listed for this record.

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References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 27, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03561987
Lead sponsor
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Responsible party
Juan Antonio Suárez Cuenca (Ph.D. in Biomedical sciences, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado) — Principal investigator
First posted
Jun 19, 2018
Start date
Nov 6, 2013
Primary completion
Dec 1, 2020 (estimated)
Completion
Jan 15, 2022 (estimated)
Last update
Jul 5, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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