NCT00732602

Brief Summary

The purpose of this study is to determine whether Glucose-dependent Insulinotropic Polypeptide (GIP) or Glucagon Like Peptide 2 (GLP-2) has an affect on the secretion of Glucagon from the pancreas in patients with type 1 diabetes mellitus.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

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

January 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2008

Completed
Last Updated

February 13, 2009

Status Verified

February 1, 2009

Enrollment Period

7 months

First QC Date

August 11, 2008

Last Update Submit

February 12, 2009

Conditions

Diabetes Mellitus

Keywords

GlucagonGlucose-dependent Insulinotropic PolypeptideGlucagon-Like peptide 2

Outcome Measures

Primary Outcomes (1)

  • plasma-glucagon Area Under Curve at 0-90 min. and 90-180 min.

Study Arms (3)

B

ACTIVE COMPARATOR

GLP-2 infusion

Other: GLP-2 infusion

C

PLACEBO COMPARATOR

Sodium-chloride infusion

Other: Sodium-chloride

A

ACTIVE COMPARATOR

GIP-infusion

Other: GIP-infusion

Interventions

GIP-infusionOTHER
A
Sodium-chlorideOTHER
C
GLP-2 infusionOTHER
B

Eligibility Criteria

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

You may qualify if:

  • Caucasians over 18 years with type 1 diabetes (WHO criteria)
  • Arginine test without rise in plasma C-peptide
  • Normal blood Hemoglobin
  • Informed consent

You may not qualify if:

  • Liver disease
  • Diabetic nephropathy
  • Treatment with medications unpausable for 12 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Gentofte

Hellerup, Capital Region, 2900, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 11, 2008

First Posted

August 12, 2008

Study Start

January 1, 2008

Primary Completion

August 1, 2008

Last Updated

February 13, 2009

Record last verified: 2009-02

Locations

DK(1)