Ghrelin Levels in Patients With Protein C Deficiency | NCT04180657

Studies
Ghrelin Levels in Patients With Protein C Deficiency

NCT04180657

Sponsor

University of Aarhus

Status

Unknown status

Last Update Posted

Nov 27, 2019Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Protein C Deficiency

Interventions

Protein C deficiency

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2020Estimated

Primary Completion Date

Apr 2020Estimated

Completion Date

Jul 2020Estimated

First Submitted Date

Oct 21, 2019

First Submission Date that Met QC Criteria

Nov 25, 2019

First Posted Date

Nov 27, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2019

Last Update Posted Date

Nov 27, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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
Healthy controls		Patient and control group are compared regarding ghrelin, growth hormone levels and appetite, and no other intervention is made.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Protein C deficiency	Genetic	The effect of protein C deficiency on ghrelin levels are investigated.	Patients with protein C deficiency

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sascha S Horup, MD	Contact	+45 27149089		SASHOR@rm.dk
Rakel F Johansen, MD	Contact			rfjohansen@clin.au.dk

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020151	Protein C Deficiency

Ancestor Terms

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

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Browse Branches

Not provided