NCT03561987

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2013

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2022

Completed
Last Updated

July 5, 2018

Status Verified

June 1, 2018

Enrollment Period

7.1 years

First QC Date

June 8, 2018

Last Update Submit

July 3, 2018

Conditions

Metabolic SyndromeDiabetes MellitusInflammatory Response

Keywords

ADIPOSE TISSUE, CARDIOVASCULAR, OBESE PATIENTS

Outcome Measures

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)

    3 years

Secondary Outcomes (2)

  • Correlation between serum concentration of pro-inflammatory biomarker and the reduction of subclinical endothelial disfunction.

    9 months

  • Determine the association of the cardiovascular prognosis modification (risk subgroups) with the basal metabolic profile.

    9 months

Study Arms (2)

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

Bariatric surgeryPROCEDURE

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.

No obese patients and abdominal surgeryObese patients and bariatric surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Morbid obese patients candidates to bariatric surgery.

You may qualify if:

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

You may not qualify if:

  • Second bariatric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Subcutaneous adipose tissue, visceral adipose tissue, liver tissue, blood samples.

MeSH Terms

Conditions

Metabolic SyndromeDiabetes Mellitus

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
9 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. in Biomedical sciences

Study Record Dates

First Submitted

June 8, 2018

First Posted

June 19, 2018

Study Start

November 6, 2013

Primary Completion

December 1, 2020

Study Completion

January 15, 2022

Last Updated

July 5, 2018

Record last verified: 2018-06