Life Style Modification Medical and Surgical Management i... | NCT04417582

Studies
Life Style Modification Medical and Surgical Management in Patients With Obesity

NCT04417582

Sponsor

Marmara University

Status

Unknown status

Last Update Posted

Jun 4, 2020Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Obesity
Weight Change, Body
Obesity; Endocrine
Obesity, Metabolically Benign

Interventions

bariatric surgey

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Dec 1, 2023Estimated

Completion Date

Dec 1, 2025Estimated

First Submitted Date

Jun 2, 2020

First Submission Date that Met QC Criteria

Jun 3, 2020

First Posted Date

Jun 4, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2020

Last Update Posted Date

Jun 4, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
life syte modification only	obese patients followed with life style modification	Procedure: bariatric surgey
medical teatment with antiobesity drugs	patients prescribed antiobesity drugs	Procedure: bariatric surgey
bariatric surgery	patients undergone bariatric surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bariatric surgey	Procedure	patients undergone bariatric surgery or prescribed antiobesity drugs	life syte modification only medical teatment with antiobesity drugs

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dilek Gogas Yavuz, MD	Contact	+902166254685		dilekgogas@marmara.edu.tr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Marmara University Medical School Section of Endocrinology and Metabolism	Recruiting	Istanbul		34899	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

data will be shared at the second year of recruitment

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D001836	Body Weight Changes
D000067329	Obesity, Metabolically Benign
D015431	Weight Loss

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077403	Orlistat

Ancestor Terms

ID	Term
D007783	Lactones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided