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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02996071
Other study ID # 2016_10/16
Secondary ID
Status Recruiting
Phase N/A
First received December 15, 2016
Last updated December 15, 2016
Start date August 2016
Est. completion date December 2017

Study information

Verified date December 2016
Source Bezmialem Vakif University
Contact Huseyin K Bektasoglu, MD
Phone +902124531700
Email hkbektasoglu@yahoo.com
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
laparoscopic sleeve gastrectomy
a sleeve gastrectomy operation that is performed laparoscopically.

Locations

Country Name City State
Turkey Bezmialem Vakif University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary weight loss rates 6 months No
Secondary overall complications 1 month No
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