Metabolic Changes in Patients With Chronic Cardiopulmonar... | NCT02550808

Studies
Metabolic Changes in Patients With Chronic Cardiopulmonary Disease

NCT02550808

Sponsor

General and Teaching Hospital Celje

Status

Unknown status

Last Update Posted

Sep 16, 2015Estimated

Enrollment

400Estimated

Phase

Not provided

Conditions

Heart Failure
Chronic Obstructive Pulmonary Disease
Malignancy
Chronic Kidney Disease

Interventions

Not provided

Countries

Slovenia

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

Sep 2015

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

Mar 2012

Primary Completion Date

Jul 2016Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Sep 3, 2015

First Submission Date that Met QC Criteria

Sep 15, 2015

First Posted Date

Sep 16, 2015Estimated

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

Sep 15, 2015

Last Update Posted Date

Sep 16, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mitja Lainscak, Professor of Internal Medicine, General and Teaching Hospital CeljePrincipal Investigator

Lead Sponsor

General and Teaching Hospital CeljeOTHER

Collaborators

Name	Class
University of Ljubljana	OTHER
General Hospital Murska Sobota	OTHER
Maastricht University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This study aims to evaluate prevalence of sarcopenia and cachexia in patients with chronic cardiopulmonary disease. The investigators will also investigate metabolic disorders like glucose metabolism, presence of metabolic syndrome, body composition and histological changes in skeletal muscle and body fat. Finally, patients will be followed for clinical endpoints.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

400Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Insulin resistance (HOMA-IR)	HOMA-IR as calculated by formula using insulin and blood glucose	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Muscle strength (Handgrip test)	Handgrip test	Baseline
Change in exercise capacity (6 minute walk test)	Determined by incremental exercise test, 6 minute walk test

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of chronic disease (Heart failure, COPD, malignancy, CKD) or no diagnosis (controls)

Exclusion Criteria:

refuse to participate

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with chronic disease (Heart failure, COPD, malignancy, CKD) and healthy controls

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mitja Lainscak	Contact			mitja.lainscak@guest.arnes.si

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
General Hospital Celje	Recruiting	Celje		SI-3000	Slovenia

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D029424	Pulmonary Disease, Chronic Obstructive
D009369	Neoplasms
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Heart failure
Chronic obstructive pulmonary disease
Chronic kidney disease
Malignancy
Controls