|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
28 September 2015 |
|
Main ID: |
NCT02550808 |
|
Date of registration:
|
03/09/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Metabolic Changes in Patients With Chronic Cardiopulmonary Disease
|
|
Scientific title:
|
Metabolic and Histological Changes in Skeletal Muscle and Fat Tissue in Patients With Chronic Cardiopulmonary Disease |
|
Date of first enrolment:
|
March 2012 |
|
Target sample size:
|
400 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT02550808 |
|
Study type:
|
Observational |
|
Study design:
|
Observational Model: Cohort, Time Perspective: Prospective
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Slovenia
| | | | | | | |
|
Contacts
|
|
Name:
|
Mitja Lainscak, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
mitja.lainscak@guest.arnes.si |
|
Affiliation:
|
|
|
|
Name:
|
Mitja Lainscak |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
mitja.lainscak@guest.arnes.si |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- diagnosis of chronic disease (Heart failure, COPD, malignancy, CKD) or no diagnosis
(controls)
Exclusion Criteria:
- refuse to participate
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Chronic Kidney Disease
|
|
Heart Failure
|
|
Malignancy
|
|
Chronic Obstructive Pulmonary Disease
|
|
Primary Outcome(s)
|
|
Insulin resistance (HOMA-IR)
[Time Frame: Baseline]
|
|
Secondary Outcome(s)
|
|
Change in insulin resistance (HOMA-IR)
[Time Frame: Baseline and after 5 weeks]
|
|
Neurohormonal activation (NT-proBNP concentration)
[Time Frame: Baseline]
|
|
Muscle strength (Handgrip test)
[Time Frame: Baseline]
|
|
Change in apoptosis in skeletal muscle (number of apoptotic cells per square mm)
[Time Frame: Baseline and after 5 weeks]
|
|
Change in exercise capacity (6 minute walk test)
[Time Frame: baseline and after 5 weeks]
|
|
Secondary ID(s)
|
|
ML-MTB-001
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|