NCT00495599

Brief Summary

The central hypothesis of our study is that metabolic and hemodynamic improvements following gastric bypass surgery are mediated by downregulation of inflammation-related adipokines produced by the intra-abdominal adipose tissue such as Visfatin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P25-P50 for phase_3 obesity

Timeline
Completed

Started Mar 2006

Longer than P75 for phase_3 obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 3, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

November 21, 2016

Status Verified

November 1, 2016

Enrollment Period

3.7 years

First QC Date

July 2, 2007

Last Update Submit

November 17, 2016

Conditions

Obesity

Keywords

ObeseAdipose TissueVisfatinGastric Bypass Surgery

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint of the study is change in mRNA levels of Visfatin.

    Levels of Visfatin will be assayed from fat tissue taken before and after gastric bypass surgery or other laparoscopic surgery.

Interventions

Cytokines assessed from fat tissuePROCEDURE

Cytokines assessed from fat tissue

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a BMI \< 35undergoing laparoscopic surgery;
  • Patients undergoing bariatric surgery with a BMI \>35kg/m2; and
  • Those patients who have had gastric by-pass that require additional surgical procedures are eligible for this research protocol.

You may not qualify if:

  • Unwilling to consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alfonso Torquati, M.D.

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2007

First Posted

July 3, 2007

Study Start

March 1, 2006

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

November 21, 2016

Record last verified: 2016-11

Locations

US(1)