Role of Aprotinin in Glucagon Degradation, Measurement by... | NCT01436734

Studies
Role of Aprotinin in Glucagon Degradation, Measurement by Radioimmunoactive Method (RIA) I125

NCT01436734

Sponsor

University Hospital, Gentofte, Copenhagen

Status

Completed

Last Update Posted

Jul 14, 2015Estimated

Enrollment

5Actual

Phase

Not Applicable

Conditions

Hyperglucagonemia

Interventions

Fasting glycemia
Hypoglycemia

Countries

Denmark

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

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Dec 2012Actual

Completion Date

May 2013Actual

First Submitted Date

Sep 8, 2011

First Submission Date that Met QC Criteria

Sep 19, 2011

First Posted Date

Sep 20, 2011Estimated

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

Jul 10, 2015

Last Update Posted Date

Jul 14, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mikkel Christensen, MD, University Hospital, Gentofte, CopenhagenPrincipal Investigator

Lead Sponsor

University Hospital, Gentofte, CopenhagenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The aim of the study was to investigate the role of the Trasylol in glucagon prevention in degradation using radioimmunoactive method with I125. Additionally different incubation time was introduced in human plasma samples after oral glucose stimulation, also in fasted and hypoglycemia blood samples from patients' type 2 diabetes. Since, the structure and the techniques for the glucagon measurement are well described nowadays.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GIP	Experimental		Other: Fasting glycemia Other: Hypoglycemia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fasting glycemia	Other	no intervention	GIP
Hypoglycemia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in plasma glucagon values measured with c-terminal specific "micro-protocol" RIA4305: 350µl of plasma (duplicate sample).		120 min

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Caucasians 18 years or older with Type 2 diabetes (WHO criteria)

Exclusion Criteria:

HbA1c >9 %
Liver disease (ALAT/ASAT >2 x upper normal limit)
Diabetic nephropathy (s-creatinine >130 µM or albuminuria)
Proliferative diabetic retinopathy (anamnestic)
Severe arteriosclerosis or heart failure (NYHA group III og IV)
Anemia
treatment with medication not applicable to pause for 12 hours
pregnancy or lactation
Fasting plasma glucose >15 mM on screening day.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mikkel Christensen, MD	Gentofte Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gentofte Hospital		Hellerup		2900	Denmark

Intervention Browse Module

MeSH Terms

ID	Term
C512983	Hig1 protein, mouse

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided