NCT00065013

Brief Summary

We will assess whether undesirable loss of lean tissue following gastric bypass surgery for obesity can be minimized by protein supplementation and exercise training.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2 obesity

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_2 obesity

Status
completed

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

March 1, 2003

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2003

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

June 24, 2010

Status Verified

January 1, 2010

Enrollment Period

3.8 years

First QC Date

July 16, 2003

Last Update Submit

June 23, 2010

Conditions

Obesity

Keywords

obesitygastric bypassobesity surgerybariatric surgeryexercise

Interventions

strength trainingBEHAVIORAL

Eligibility Criteria

Age18 Years - 52 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
* clinically severe obesity * candidate for bypass surgery * new york city local address * willing to visit hospital weekly

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Allan Geliebter, PhD

    St. Luke's-Roosevelt Hospital Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

July 16, 2003

First Posted

July 18, 2003

Study Start

March 1, 2003

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

June 24, 2010

Record last verified: 2010-01