NCT00552942

Brief Summary

To see if removing the omentum in addition to a gastric bypass improves diabetes is better than just a gastric bypass.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3 diabetes

Timeline
Completed

Started Jul 2006

Typical duration for phase_3 diabetes

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

November 2, 2007

Status Verified

November 1, 2007

First QC Date

November 1, 2007

Last Update Submit

November 1, 2007

Conditions

DiabetesInterleukinsCytokines

Keywords

obesitydiabetescytokines

Outcome Measures

Primary Outcomes (1)

  • diabetic indices

    6 months

Secondary Outcomes (1)

  • interleukin and cytokine levels, weight loss

    6 months

Study Arms (2)

1

EXPERIMENTAL

surgery plus omentectomy

Procedure: laparoscopic gastric bypass plus omentectomy

2

NO INTERVENTION

standard gastric bypass

Interventions

laparoscopic gastric bypass plus omentectomyPROCEDURE
1

Eligibility Criteria

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

You may qualify if:

  • undergoing laparoscopic gastric bypass, \>18 yo, understands english

You may not qualify if:

  • previous lower pelvic surgery, self-pay patients, previous weight loss surgery,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Weight Loss Surgery LLC

Portland, Oregon, 97210, United States

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusObesity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dennis Hong, MD., MS.c, FRCSC

    Oregon Weight Loss Surgery, LLC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dennis Hong, MD, MS.c, FRCSC

CONTACT

503-227-5050dennishong70@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 2007

First Posted

November 2, 2007

Study Start

July 1, 2006

Study Completion

July 1, 2008

Last Updated

November 2, 2007

Record last verified: 2007-11

Locations

US(1)