Ghrelin Levels in Patients With Protein C Deficiency

November 25, 2019 updated by: University of Aarhus

Investigation of Ghrelin Levels in Patients With Protein C Deficiency

In rodents with protein C deficiency elevated levels of ghrelin has been observed. The purpose of this study is to investigate if patients with protein C deficiency also have elevated levels of ghrelin, and if so, how this affects the patients.

30 patients with protein C deficiency and 30 healthy BMI and gender matched controls are recruited. Bloodsamples are taken in order to measure ghrelin and GH levels and other metabolic parameters. The patients and controls are also asked to answer a questionaire regarding appetite.

If patients with protein C deficiency have higher levels of ghrelin than the general population, this will lead to new studies that will perhaps help us understand the importance of ghrelin in humans.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

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

  • Name: Sascha S Horup, MD
  • Phone Number: +45 27149089
  • Email: SASHOR@rm.dk

Study Contact Backup

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with protein C deficiency and gender and BMI matched controls.

Description

Inclusion Criteria:

  • protein C deficiency or healthy subjects
  • age 18-70
  • BMI 18-35
  • written statement to join the study

Exclusion Criteria:

  • chronic illness, apart from protein C deficiency and lifestyle diseases
  • everyday medication apart from statins, oral diabetes medication and antihypertensive drugs.
  • blood donation within three months prior to the investigation.
  • Alcohol abuse

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
Intervention / Treatment
Patients with protein C deficiency
Patient and control group are compared regarding ghrelin, growth hormone levels and appetite, and no other intervention is made.
Genetic: Protein C deficiency
The effect of protein C deficiency on ghrelin levels are investigated.
Healthy controls
Patient and control group are compared regarding ghrelin, growth hormone levels and appetite, and no other intervention is made.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
acyl ghrelin and des acyl ghrelin measured in mg/dl
Time Frame: 6 month
6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Growth hormone measured in pmol/L
Time Frame: 6 month
6 month

Collaborators and Investigators

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

Sponsor

University of Aarhus

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 (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

October 21, 2019

First Submitted That Met QC Criteria

November 25, 2019

First Posted (Actual)

November 27, 2019

Study Record Updates

Last Update Posted (Actual)

November 27, 2019

Last Update Submitted That Met QC Criteria

November 25, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69965

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Protein C Deficiency

Clinical Trials on Protein C deficiency

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe