Life Style Modification Medical and Surgical Management in Patients With Obesity

June 3, 2020 updated by: Marmara University

Evaluation of Life Style Modification Medical and Surgical Treatment Modalities in Patients With Obesity: An Observational Study

In this is an observational study, obese patients that administed and followed in endocrinology clinic of Marmara University Medical school hospital will follow for clinical and laboratory parameters prospectively for 5 years

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Following available clinical and laboratory parameters will be collected for 5 years Treatment modalities ( life stye modification, medication, bariatric surgery) eating habits quality of life body mass index , blood pressure body fat distribution (impedance measurement) laboratory parameters (serum glucose, OGTT, insülin, lipids,creatinin ,ALT AST,CBC, ferritin calcium, phosphate, Parathormone,25 OH vitamin D, vitamin B12 ,uric acid, albumin, FSH LH testosteron, estrogen ) muscle strength (dynomometer measurement) skin glikolization autoflouresent measurement Bone mineral density mesurements (femur, spine ,forarm)

Study Type

Observational

Enrollment (Anticipated)

1000

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, 34899
        • Recruiting
        • Marmara University Medical School Section of Endocrinology and Metabolism

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

Sampling Method

Non-Probability Sample

Study Population

obese patients refered to our tertiary center for obesity evaluation or treatment

Description

Inclusion Criteria:

Body mass index over 30 kg/m2 age between 18-65 years

Exclusion Criteria:

active malignancy pregnancy during involvement period chronic inflamatuar diseases

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
life syte modification only
obese patients followed with life style modification
Procedure: bariatric surgey
patients undergone bariatric surgery or prescribed antiobesity drugs
Other Names:
  • antiobesity drugs ,liraglutide or orlistat
medical teatment with antiobesity drugs
patients prescribed antiobesity drugs
Procedure: bariatric surgey
patients undergone bariatric surgery or prescribed antiobesity drugs
Other Names:
  • antiobesity drugs ,liraglutide or orlistat
bariatric surgery
patients undergone bariatric surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight loss
Time Frame: 6 months interval
%5-10 weight loss
6 months interval
metabolic improvement
Time Frame: 6 months interval
blood glucose
6 months interval
metabolic improvement
Time Frame: 6 month
serum lipid levels
6 month

Collaborators and Investigators

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

Sponsor

Marmara 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 (Actual)

January 1, 2020

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

June 2, 2020

First Submitted That Met QC Criteria

June 3, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 3, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2019.948

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

data will be shared at the second year of recruitment

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Obesity

Clinical Trials on bariatric surgey

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe