NCT02996071

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
unknown

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, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 19, 2016

Status Verified

December 1, 2016

Enrollment Period

10 months

First QC Date

December 15, 2016

Last Update Submit

December 15, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • weight loss rates

    6 months

Secondary Outcomes (1)

  • overall complications

    1 month

Study Arms (2)

low waist to height ratio

ACTIVE COMPARATOR

laparoscopic sleeve gastrectomy

Procedure: laparoscopic sleeve gastrectomy

high waist to height ratio

ACTIVE COMPARATOR

laparoscopic sleeve gastrectomy

Procedure: laparoscopic sleeve gastrectomy

Interventions

a sleeve gastrectomy operation that is performed laparoscopically.

high waist to height ratiolow waist to height ratio

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • BMI\>40 kg/m2
  • Sleeve gastrectomy operation planned patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Istanbul, 34090, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Huseyin K Bektasoglu, MD

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Huseyin K Bektasoglu, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2016

First Posted

December 19, 2016

Study Start

August 1, 2016

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

December 19, 2016

Record last verified: 2016-12

Locations