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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04180657
Other study ID # 69965
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 2020
Est. completion date July 2020

Study information

Verified date October 2019
Source University of Aarhus
Contact Sascha S Horup, MD
Phone +45 27149089
Email SASHOR@rm.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date July 2020
Est. primary completion date April 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Genetic:
Protein C deficiency
The effect of protein C deficiency on ghrelin levels are investigated.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Outcome

Type Measure Description Time frame Safety issue
Primary acyl ghrelin and des acyl ghrelin measured in mg/dl 6 month
Secondary Growth hormone measured in pmol/L 6 month
See also
  Status Clinical Trial Phase
Completed NCT01127529 - Ceprotin Treatment Registry
Completed NCT00161720 - Retrospective Study to Capture Dosing and Treatment Outcome Data in Participants With Severe Congenital Protein C Deficiency Who Were Treated With Protein C Concentrate Under an Emergency Use IND
Completed NCT00157118 - Efficacy and Safety Study of Protein C Concentrate in Subjects With Severe Congenital Protein C Deficiency Phase 2/Phase 3