NCT00832741

Brief Summary

The purpose of this study is to investigate whether secretion of incretin hormones is intact and to what extent endogenous as well as exogenous GLP-1 controls postprandial glucose excursions in patients with type-1 diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2008

Shorter than P25 for all trials

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

May 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2009

Completed
Last Updated

January 30, 2009

Status Verified

January 1, 2009

Enrollment Period

5 months

First QC Date

January 29, 2009

Last Update Submit

January 29, 2009

Conditions

Type 1 Diabetes

Keywords

GLP-1Type 1 diabetesGlycemic controlIncretin hormone

Outcome Measures

Primary Outcomes (1)

  • blood glucose

    4 hours

Secondary Outcomes (4)

  • GLP-1 and GIP response during a meal

    4 hours

  • betacell function (incremental area under the c-peptide concentration curve)

    4 hours

  • alfa cell function (plasma glucagon)

    4 hours

  • gastric emptying

    4 hours

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic patients and community population(control subjects)

You may qualify if:

  • type-1 diabetes mellitus
  • diagnosis between 5-40 years.
  • age 18-60 year
  • normal weight at time of diagnosis
  • insulintreatment from diagnosis
  • HbA1c \< 7.6 %

You may not qualify if:

  • diabetic complications
  • disease other than type-1 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, plasma

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Urd Kielgast, MD

    unafilliated

    STUDY DIRECTOR

  • Sten Madsbad, MD, DMSc

    Unafilliated

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 29, 2009

First Posted

January 30, 2009

Study Start

May 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

January 30, 2009

Record last verified: 2009-01

Locations

DK(1)