NCT01436734

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2011

Typical duration for not_applicable

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

July 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 20, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

July 14, 2015

Status Verified

July 1, 2015

Enrollment Period

1.4 years

First QC Date

September 8, 2011

Last Update Submit

July 10, 2015

Conditions

Hyperglucagonemia

Outcome Measures

Primary Outcomes (1)

  • Change in plasma glucagon values measured with c-terminal specific "micro-protocol" RIA4305: 350µl of plasma (duplicate sample).

    120 min

Study Arms (1)

GIP

EXPERIMENTAL
Other: Fasting glycemiaOther: Hypoglycemia

Interventions

Fasting glycemiaOTHER

no intervention

GIP
HypoglycemiaOTHER

Insulin induced hypoglycemia

GIP

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gentofte Hospital

Hellerup, 2900, Denmark

Location

MeSH Terms

Interventions

Hig1 protein, mouse

Study Officials

  • Mikkel Christensen, MD

    Gentofte Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 8, 2011

First Posted

September 20, 2011

Study Start

July 1, 2011

Primary Completion

December 1, 2012

Study Completion

May 1, 2013

Last Updated

July 14, 2015

Record last verified: 2015-07

Locations

DK(1)