NCT03584607

Brief 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 data from healthy controls.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 12, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

1.1 years

First QC Date

May 14, 2018

Last Update Submit

January 24, 2020

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (1)

  • Insulin resistance

    Determination of insulin sensitivity using hyperinsulinemic-euglycemic clamp technique

    1 day

Study Arms (2)

Idiopathic Pulmonary Arterial Hypertension patients

Blood sampling Insulin resistance-measurement

Healthy controls

Blood sampling Insulin resistance-measurement

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy controls, or patients with idiopathic or hereditary pulmonary hypertension

You may qualify if:

  • signed informed consent form
  • patients with idiopathic or hereditary pulmonary hypertension / healthy controls

You may not qualify if:

  • premenopausal women
  • other relevant lung disease
  • relevant left heart disease
  • untreated systemic hypertension
  • Diabetes mellitus
  • pulmonary hypertension other than idiopathic or hereditary form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Graz, Division of Pulmonology

Graz, Styria, 8010, Austria

Location

Related Publications (1)

  • 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.

    PMID: 32217652DERIVED

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Bence M. Nagy, PhD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2018

First Posted

July 12, 2018

Study Start

December 20, 2017

Primary Completion

February 11, 2019

Study Completion

February 11, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations

AU(1)