May Preoperative Waist to Height Ratio Predict Postoperative Weight Loss in Bariatric Patients?
Primary Purpose
Bariatric Surgery Candidate, Obesity, Morbid
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
laparoscopic sleeve gastrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Bariatric Surgery Candidate
Eligibility Criteria
Inclusion Criteria:
- 18-65 years old
- BMI>40 kg/m2
- Sleeve gastrectomy operation planned patients
Exclusion Criteria:
- Type 1 or 2 diabetes mellitus
- osteoarticular pathology that may restrict postoperative regular physical activity.
- apparent mental or psychological disorder that may affect postoperative recommendations
- refusal of informed consent for this study
Sites / Locations
- Bezmialem Vakif UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
low waist to height ratio
high waist to height ratio
Arm Description
laparoscopic sleeve gastrectomy
laparoscopic sleeve gastrectomy
Outcomes
Primary Outcome Measures
weight loss rates
Secondary Outcome Measures
overall complications
Full Information
NCT ID
NCT02996071
First Posted
December 15, 2016
Last Updated
December 15, 2016
Sponsor
Bezmialem Vakif University
1. Study Identification
Unique Protocol Identification Number
NCT02996071
Brief Title
May Preoperative Waist to Height Ratio Predict Postoperative Weight Loss in Bariatric Patients?
Official Title
May Preoperative Waist to Height Ratio Predict Postoperative Weight Loss in Bariatric Patients?
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Bariatric surgery is an effective method for treatment of obesity. Sleeve gastrectomy is one of surgical methods and became popular in recent years. Weight loss rates after bariatric surgery differs among patients. The exact reason of this difference stays unclear. age, nationality, difference between body composition and type of surgery may be in concern. waist to height ratio has become popular recent years as an indicator of cardiomethabolic status. in this study, investigation of the effect of waist to height ratio differences of patients on weight loss following laparoscopic sleeve gastrectomy as a bariatric surgery.
Detailed Description
Waist to height raito is the major determinator of patients and will be noted in every patient who will fulfil the eligibility criteras defined below and undergo laparoscopic sleeve gastrectomy. demographic data, BMI, body lipid composition, lean body weight also will be noted. all patients will undergo standardized laparoscopic sleeve gastrectomy operation. patients will be follow up during first, third, sixth and one year periods. all parameters noted preoperatively will be measured and noted again. possible statistical difference will be calculated statistically and a cut off value will be seeked.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate, Obesity, Morbid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
low waist to height ratio
Arm Type
Active Comparator
Arm Description
laparoscopic sleeve gastrectomy
Arm Title
high waist to height ratio
Arm Type
Active Comparator
Arm Description
laparoscopic sleeve gastrectomy
Intervention Type
Procedure
Intervention Name(s)
laparoscopic sleeve gastrectomy
Intervention Description
a sleeve gastrectomy operation that is performed laparoscopically.
Primary Outcome Measure Information:
Title
weight loss rates
Time Frame
6 months
Secondary Outcome Measure Information:
Title
overall complications
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-65 years old
BMI>40 kg/m2
Sleeve gastrectomy operation planned patients
Exclusion Criteria:
Type 1 or 2 diabetes mellitus
osteoarticular pathology that may restrict postoperative regular physical activity.
apparent mental or psychological disorder that may affect postoperative recommendations
refusal of informed consent for this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huseyin K Bektasoglu, MD
Phone
+902124531700
Email
hkbektasoglu@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huseyin K Bektasoglu, MD
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
ZIP/Postal Code
34090
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huseyin K Bektasoglu, MD
Phone
+902124531700
Ext
2450
Email
hkbektasoglu@yahoo.com
First Name & Middle Initial & Last Name & Degree
Lutfullah Baskoy, MD
Phone
+902124531700
Ext
2452
Email
mdbaskoy@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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May Preoperative Waist to Height Ratio Predict Postoperative Weight Loss in Bariatric Patients?
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