- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03584607
Insulin- and Glucose Metabolism in Pulmonary Arterial Hypertension
January 24, 2020 updated by: Medical University of Graz
Insulin- and Glucose Metabolism in Pulmonary Arterial Hypertension - a Pilot Study
Insulin resistance is a key mechanism in metabolic disorders, which has also been implicated in the development of pulmonary hypertension.
In this pilot study, the investigators´ goal is to directly determine insulin sensitivity in idiopathic pulmonary arterial hypertension patients and to compare the results with data from healthy controls.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Steiermark
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Graz, Steiermark, Austria, 8010
- Medical University Graz, Division of Pulmonology
-
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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 to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy controls, or patients with idiopathic or hereditary pulmonary hypertension
Description
Inclusion Criteria:
- signed informed consent form
- patients with idiopathic or hereditary pulmonary hypertension / healthy controls
Exclusion Criteria:
- premenopausal women
- other relevant lung disease
- relevant left heart disease
- untreated systemic hypertension
- Diabetes mellitus
- pulmonary hypertension other than idiopathic or hereditary form
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
Cohorts and Interventions
Group / Cohort |
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Idiopathic Pulmonary Arterial Hypertension patients
Blood sampling Insulin resistance-measurement
|
Healthy controls
Blood sampling Insulin resistance-measurement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin resistance
Time Frame: 1 day
|
Determination of insulin sensitivity using hyperinsulinemic-euglycemic clamp technique
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bence M. Nagy, PhD, Medical University of Graz
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (ACTUAL)
December 20, 2017
Primary Completion (ACTUAL)
February 11, 2019
Study Completion (ACTUAL)
February 11, 2019
Study Registration Dates
First Submitted
May 14, 2018
First Submitted That Met QC Criteria
July 11, 2018
First Posted (ACTUAL)
July 12, 2018
Study Record Updates
Last Update Posted (ACTUAL)
January 27, 2020
Last Update Submitted That Met QC Criteria
January 24, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29-066 ex 16/17
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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