Metabolic Changes in Patients With Chronic Cardiopulmonary Disease

September 15, 2015 updated by: Mitja Lainscak, General and Teaching Hospital Celje

Metabolic and Histological Changes in Skeletal Muscle and Fat Tissue in Patients With Chronic Cardiopulmonary Disease

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • refuse to participate

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
Chronic kidney disease
Controls
Heart failure
Chronic obstructive pulmonary disease
Malignancy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle strength (Handgrip test)
Time Frame: Baseline
Handgrip test
Baseline
Change in exercise capacity (6 minute walk test)
Time Frame: baseline and after 5 weeks
Determined by incremental exercise test, 6 minute walk test
baseline and after 5 weeks
Neurohormonal activation (NT-proBNP concentration)
Time Frame: Baseline
NT-proBNP concentration
Baseline
Change in apoptosis in skeletal muscle (number of apoptotic cells per square mm)
Time Frame: Baseline and after 5 weeks
histological evaluation: number of apoptotic cells per square mm
Baseline and after 5 weeks
Change in insulin resistance (HOMA-IR)
Time Frame: Baseline and after 5 weeks
HOMA-IR as calculated by formula using insulin and blood glucose
Baseline and after 5 weeks

Collaborators and Investigators

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

Sponsor

General and Teaching Hospital Celje

Collaborators

Maastricht University
University of Ljubljana
General Hospital Murska Sobota

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

March 1, 2012

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 3, 2015

First Submitted That Met QC Criteria

September 15, 2015

First Posted (Estimate)

September 16, 2015

Study Record Updates

Last Update Posted (Estimate)

September 16, 2015

Last Update Submitted That Met QC Criteria

September 15, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML-MTB-001

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.

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