BP Limb Length of 60cm vs 100cm in Roux-en-Y Gastric Bypass
Primary Purpose
Osteopenia
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
biliopancreatic limb length of 60cm.
biliopancreatic limb length of 100cm.
Sponsored by
About this trial
This is an interventional diagnostic trial for Osteopenia
Eligibility Criteria
Inclusion Criteria:
- Body mass index >40 Kg/m2
- Body mass index >35 Kg/m2 associated to obesity related comorbidities
Exclusion Criteria:
- Bone pathologies
- Active neoplasms
- Disorders in calcium or vitamin D metabolism
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Biliopancreatic limb 60cm
Biliopancreatic limb 100cm
Arm Description
Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 60cm.
Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 100cm.
Outcomes
Primary Outcome Measures
Bone mineral density
Bone mineral density will be evealuated by absorptiometry at the level of lumbar column
Secondary Outcome Measures
Full Information
NCT ID
NCT04377230
First Posted
May 2, 2020
Last Updated
May 2, 2020
Sponsor
Hospital General Universitario Elche
Collaborators
Instituto de Seguridad Social del Estado de Mexico y Municipios
1. Study Identification
Unique Protocol Identification Number
NCT04377230
Brief Title
BP Limb Length of 60cm vs 100cm in Roux-en-Y Gastric Bypass
Official Title
Impact of Biliopancreatic Limb Length of 60cm vs 100cm in Roux-en-Y Gastric Bypass on Bone Mineral Density 2 Years After Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 7, 2020 (Anticipated)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario Elche
Collaborators
Instituto de Seguridad Social del Estado de Mexico y Municipios
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients will be randomized into 2 groups:
Group 60: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 60cm
Group 100: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 100cm
Bone mineral density will be evaluated before surgery and 2 years after it.
Detailed Description
Patients will be randomized into 2 groups:
Group 60: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 60cm
Group 100: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 100cm Alimentary limb will be constant in both groups (150cm length)
Bone mineral density will be evaluated before surgery and 2 years after it, by means of X ray absorptiometry (DEXA). Changes in bone mineral density in lumbar column will be assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The radiologist evaluating bone mineral density will be blinded to the biliopancreatic limb length
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biliopancreatic limb 60cm
Arm Type
Experimental
Arm Description
Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 60cm.
Arm Title
Biliopancreatic limb 100cm
Arm Type
Active Comparator
Arm Description
Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 100cm.
Intervention Type
Procedure
Intervention Name(s)
biliopancreatic limb length of 60cm.
Intervention Description
Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 60cm.
Intervention Type
Procedure
Intervention Name(s)
biliopancreatic limb length of 100cm.
Intervention Description
Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 100cm.
Primary Outcome Measure Information:
Title
Bone mineral density
Description
Bone mineral density will be evealuated by absorptiometry at the level of lumbar column
Time Frame
2 years after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Body mass index >40 Kg/m2
Body mass index >35 Kg/m2 associated to obesity related comorbidities
Exclusion Criteria:
Bone pathologies
Active neoplasms
Disorders in calcium or vitamin D metabolism
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carolina LLavero Garrido
Phone
649593020
Email
carolinallavero@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gilberto Gonzalez
Phone
+5213322545864
Email
gilpchmd@yahoo.com.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime Ruiz-Tovar
Organizational Affiliation
Garcilaso Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
BP Limb Length of 60cm vs 100cm in Roux-en-Y Gastric Bypass
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