Insulin ResistanceNCT03584607
Insulin- and Glucose Metabolism in Pulmonary Arterial Hypertension
An observational study of Insulin Resistance, run by Medical University of Graz at 1 site in Austria.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- 20 Dec 2017to 11 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy controls, or patients with idiopathic or hereditary pulmonary hypertension
Who may be able to join
- signed informed consent form
- patients with idiopathic or hereditary pulmonary hypertension / healthy controls
Who cannot join
- premenopausal women
- other relevant lung disease
- relevant left heart disease
- untreated systemic hypertension
- Diabetes mellitus
- pulmonary hypertension other than idiopathic or hereditary form
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University Graz, Division of Pulmonology
Graz, Styria, 8010
About this study
Official title: 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.
- Conditions
- Insulin Resistance
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic Pulmonary Arterial Hypertension patients | Blood sampling Insulin resistance-measurement | |
| Healthy controls | Blood sampling Insulin resistance-measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance
Determination of insulin sensitivity using hyperinsulinemic-euglycemic clamp technique
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start20 Dec 2017
- Primary completion11 Feb 2019
- Study completion11 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bence M. Nagy, PhD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584607
- Sponsor's protocol ID
- 29-066 ex 16/17
- Status last verified
- Jan 2020
- First submitted
- 14 May 2018
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nagy BM, Kovacs G, Tornyos A, Svehlikova E, Foris V, Nagaraj C, Kwapiszewska G, Pieber TR, Olschewski A, Olschewski H. No indication of insulin resistance in idiopathic pulmonary arterial hypertension with preserved physical activity. Eur Respir J. 2020 Jun 11;55(6):1901228. doi: 10.1183/13993003.01228-2019. Print 2020 Jun. No abstract available.
PubMed 32217652
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin- and Glucose Metabolism in Pulmonary Arterial Hypertension - a Pilot Study
- ClinicalTrials.gov ID
- NCT03584607
- Acronym / sponsor ID
- 29-066 ex 16/17
- Conditions
- Insulin Resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 11 Feb 2019 (actual)
- Study completion
- 11 Feb 2019 (actual)
- First posted
- 12 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Idiopathic Pulmonary Arterial Hypertension patients | – | –Blood sampling Insulin resistance-measurement |
| Healthy controls | – | –Blood sampling Insulin resistance-measurement |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy controls, or patients with idiopathic or hereditary pulmonary hypertension
Key inclusion criteria (2 listed)
- signed informed consent form
- patients with idiopathic or hereditary pulmonary hypertension / healthy controls
Key exclusion criteria (6 listed)
- premenopausal women
- other relevant lung disease
- relevant left heart disease
- untreated systemic hypertension
- Diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Insulin resistance
Time frame: 1 day
Determination of insulin sensitivity using hyperinsulinemic-euglycemic clamp technique
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Derived from this study: PubMed 32217652Nagy BM, Kovacs G, Tornyos A, Svehlikova E, Foris V, Nagaraj C, Kwapiszewska G, Pieber TR, Olschewski A, Olschewski H. No indication of insulin resistance in idiopathic pulmonary arterial hypertension with preserved physical activity. Eur Respir J. 2020 Jun 11;55(6):1901228. doi: 10.1183/13993003.01228-2019. Print 2020 Jun. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bence M. Nagy, PhD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Resistance, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin resistance (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03584607, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.