NCT00603031

Brief Summary

study hypothesis: treatment with GLP-1 and/or GIP is able to potentiate the maximal stimulated insulin secretion even in c-peptide negative type-1 diabetic patients classified as having no residual beta cell function left.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Shorter than P25 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

January 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

January 21, 2011

Status Verified

August 1, 2009

Enrollment Period

5 months

First QC Date

January 15, 2008

Last Update Submit

January 20, 2011

Conditions

Type-1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • phase insulin response and phase insulin response measured as incremental area under the curve from 0-10 minutes and incremental area under the curve from 10-45 minutes respectively after iv glucose

    2 hours

Secondary Outcomes (1)

  • maximal insulin response defined as mean insulin at time 47 and 49 minutes (2 and 4 minutes after infusion of L-Arginine)

    2 hours

Study Arms (3)

GLP-1

EXPERIMENTAL

time -30-90 min: Continuous infusion with GLP-1 (1,2pmol/kg/min) time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g).

Other: glucagon like peptide -1

NaCl

PLACEBO COMPARATOR

time -30-90 min: Continuous infusion with NaCl time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g).

Other: NaCl

GIP

EXPERIMENTAL

time -30-90 min: Continuous infusion with GIP-1 (3,6pmol/kg/min) time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g).

Other: glucose dependent insulinotropic polypeptide

Interventions

glucagon like peptide -1OTHER

continuous infusion 1,2 pmol pr. kg pr minute at 120 minutes

GLP-1
NaClOTHER

infusion with NaCl for 120 minutes as placebo-arm

NaCl
glucose dependent insulinotropic polypeptideOTHER

continuous infusion with GIP-1 (3,6pmol/kg/min) at 120 minutes.

GIP

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-60 years
  • Type-1 diabetes diagnosed between 5-40 years of age
  • Normal weight(BMI 18-27),
  • Insulin treatment from time of diagnosis.

You may not qualify if:

  • Severe complications to diabetes
  • Abnormal liver or kidney function
  • Haemoglobin below the lower limit
  • Macroalbuminuria
  • Systemic disease
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Endocrinology, Hvidovre Hospital

Copenhagen, 2650, Denmark

Location

MeSH Terms

Interventions

Glucagon-Like Peptide 1Incretins

Intervention Hierarchy (Ancestors)

Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Urd Kielgast, MD

    unafilliated

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 15, 2008

First Posted

January 28, 2008

Study Start

January 1, 2008

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

January 21, 2011

Record last verified: 2009-08

Locations

DK(1)