May Preoperative Waist to Height Ratio Predict Postoperative Weight Loss in Bariatric Patients?

December 15, 2016 updated by: Bezmialem Vakif University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34090
        • Recruiting
        • Bezmialem Vakif University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: low waist to height ratio
laparoscopic sleeve gastrectomy
Procedure: laparoscopic sleeve gastrectomy
a sleeve gastrectomy operation that is performed laparoscopically.
Active Comparator: high waist to height ratio
laparoscopic sleeve gastrectomy
Procedure: laparoscopic sleeve gastrectomy
a sleeve gastrectomy operation that is performed laparoscopically.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
weight loss rates
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
overall complications
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Investigators

  • Principal Investigator: Huseyin K Bektasoglu, MD, Bezmialem Vakif University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

December 15, 2016

First Submitted That Met QC Criteria

December 15, 2016

First Posted (Estimate)

December 19, 2016

Study Record Updates

Last Update Posted (Estimate)

December 19, 2016

Last Update Submitted That Met QC Criteria

December 15, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016_10/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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