NCT01153308

Brief Summary

The purpose of this registry is to monitor and evaluate the efficacy, as well as safety, of bariatric surgery performed at UMass Memorial Medical Center, including laparoscopic gastric bypass surgery and laparoscopic gastric banding, in the surgical treatment of morbid obesity and associated co-morbidities such as type 2 diabetes, sleep apnea and cardiovascular disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,785

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2005

Longer than P75 for all trials

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

April 1, 2005

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 30, 2010

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

10 years

First QC Date

March 21, 2010

Last Update Submit

August 17, 2015

Conditions

Morbid Obesity

Keywords

Morbid ObesityObesityWeight LossBariatric Surgery

Outcome Measures

Primary Outcomes (1)

  • Weight Loss after surgery

    Baseline weight is recorded preoperatively. Time points after surgery when weight is recorded are two weeks, six weeks, 6 months, 1 year, 18 months, 2 years, then annually on the anniversary date of surgery.

    Preop, Postop, Six Months, and Annually

Secondary Outcomes (1)

  • Resolution of Co-morbidities, such as Type 2 Diabetes, Sleep Apnea, Hypertension

    Preop, Postop, Six Months, Annually

Study Arms (1)

Bariatric Surgery Patients

Bariatric Surgery patients at UMass Memorial Medical Center

Other: Observational Study

Interventions

Observational StudyOTHER

This is an Observational study

Bariatric Surgery Patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

UMMMC Bariatric Surgery Patients

You may qualify if:

  • Must be scheduled for Bariatric Surgery @ UMMMC

You may not qualify if:

  • Not scheduled for Bariatric Surgery @ UMMMC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Related Links

MeSH Terms

Conditions

Obesity, MorbidObesityWeight Loss

Interventions

Observation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • John J Kelly, MD

    University of Massachusetts Medical School and UMass Memorial Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2010

First Posted

June 30, 2010

Study Start

April 1, 2005

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

August 19, 2015

Record last verified: 2015-08

Locations

US(1)