NCT01447316

Brief Summary

This is a short term study of the effects of bariatric surgery on body composition, gait parameters during walking, lower extremity joint pain and quality of life (QOL) in morbidly obese patients who are already scheduled for a bariatric surgical procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2009

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

3.4 years

First QC Date

October 4, 2011

Last Update Submit

January 16, 2013

Conditions

Obesity, Morbid

Keywords

body compositiongaitquality of lifePatientsundergoingbariatric surgery.

Outcome Measures

Primary Outcomes (1)

  • Body Composition, describes change in body composition from pre-op levels

    To track changes in body composition and mass during the study, body weight body fat mass, fat free mass will be collected prior to and 2 and 4 weeks after the bariatric surgery using air plethysmography. Air plethysmography (using the BOD POD®) is a reliable technique of body volume and composition, and has been validated for use in obese individuals and is highly correlated to the gold standard of body composition assessment, underwater weighing.

    Describes change over a period of 4 weeks; measured at pre-op, 2 and 4 weeks following surgery

Secondary Outcomes (3)

  • Gait Analysis, describes change in gait parameters from pre-op levels

    Describes changes in gait parameters over a 3 month period; measured at pre-op, 4 weeks and 3 months following surgery.

  • Lower Extremity Joint Pain, describes change from pre-op using a Visual Analog Scale (VAS).

    Describes change in lower extremity joint pain over a period of 3 months; measured with a (VAS) at per-op, 4 weeks and 3 months following surgery

  • Medical Outcomes Short Form (SF-36), describes change in perceived quality of life (QOL)

    Describes perceived (QOL) over a period of 3 months, measured at pre-op, 4 weeks and 3 months following surgery

Study Arms (1)

Bariatric surgery

Patients undergoing bariatric surgery for weight loss.

Other: Subject outcomes following bariatric surgery

Interventions

Subject outcomes following bariatric surgeryOTHER

Subject outcomes (body composition, gait analysis, lower extremity joint pain and perceived quality of life) measured at per-op, 2, 4 weeks and 3 months.

Bariatric surgery

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All subjects will be patients already scheduled to undergo bariatric surgery for weight loss.

You may qualify if:

  • no urgent need for bariatric procedure
  • years of age
  • body mass index (BMI) 35 kg/m2 or greater, defined as morbid obesity
  • waist circumference of \< 66 inches
  • able to walk independently

You may not qualify if:

  • \< 21 or \> 65 years of age
  • pregnancy; psychiatric conditions; binge eating patterns; Prader-Willi syndrome; drug dependency; dementia or other neurodegenerative diseases that would preclude appropriate cognitive or physical ability to perform study protocol
  • uncontrolled diabetes (not using meds)
  • waist circumference of \> 66 inches
  • orthopedic conditions that prevent ambulation (severe painful osteoarthritis of the hip or knee)
  • patient is wheelchair bound

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF&Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32607, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Heather K Vincent, Ph.D.

    University of Florida Department of Orthopaedics and Rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 4, 2011

First Posted

October 6, 2011

Study Start

August 1, 2009

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

January 17, 2013

Record last verified: 2013-01

Locations

US(1)