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NCT04417582 Clinical Trial

Life Style Modification Medical and Surgical Management in Patients With Obesity

Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04417582
Other study ID # 09.2019.948
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date December 1, 2025

Study information
Verified date June 2020
Source Marmara University
Contact Dilek Gogas Yavuz, MD
Phone +902166254685
Email dilekgogas@marmara.edu.tr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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)

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date December 1, 2025
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• bariatric surgey
patients undergone bariatric surgery or prescribed antiobesity drugs

Locations
Country Name City State
Turkey Marmara University Medical School Section of Endocrinology and Metabolism Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary weight loss %5-10 weight loss 6 months interval
Primary metabolic improvement blood glucose 6 months interval
Primary metabolic improvement serum lipid levels 6 month
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