NCT02235584

Brief Summary

In this study we examine whether inducing insulin resistance by dexamethasone in healthy volunteers will lead to a decreased insulinotropic effect of the hormones GLP-1 and GIP.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable type-2-diabetes

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, 2009

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 10, 2014

Completed
Last Updated

September 10, 2014

Status Verified

September 1, 2014

Enrollment Period

4.9 years

First QC Date

September 7, 2014

Last Update Submit

September 7, 2014

Conditions

Keywords

Incretin hormonesGLP-1GIPDexamethasone

Outcome Measures

Primary Outcomes (1)

  • The potentiating effects of GLP-1 on second phase insulin response when clamped at at bloodsugar of 7 mmol/l

    After dexamethasone treatment subjects are tested with infusion of GLP-1 during a clamped blood-sugar of 7mmol/l. Their increase in the second phase insulin response is the primary endpoint.

    1-3 days after dexamethasone treatment

Secondary Outcomes (3)

  • First phase insulin response to GLP-1 infusion at 7mmol/l

    1-3 days after dexamethasone

  • First phase insulin response to GIP infusion at 7mmol/l

    1-3 days after dexamethasone

  • Second phase insulin response to GIP infusion at 7mmol/l

    1-3 days after dexamethasone treatment

Other Outcomes (1)

  • Total insulin response to arginine infusion

    1-3 days after dexamethasone

Study Arms (1)

Dexamethasone

EXPERIMENTAL

This is a before-after study. All subjects are administered dexamethasone 2mg BID for 5 days.

Drug: Dexamethasone

Interventions

Dexamethasone are given dexamethasone tablets of 2mg twice daily.

Dexamethasone

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Caucasians above 20 and below 45 years of age
  • Normal glucose tolerance as assessed by the WHO criteria
  • First degree relative and at least 1 second degree relative with type 2 diabetes
  • Normal haemoglobin
  • Informed consent

You may not qualify if:

  • Liver disease (ALAT/ASAT \> 2 times normal value)
  • Kidney disease (S-creatinin \> 130uM and/or albuminuria)
  • Heart disease (NYHA II, III or IV)
  • Treatment with medicine that cannot be paused
  • Pregnancy of breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg University Hospital

Copenhagen NV, 2400, Denmark

Location

Related Publications (1)

  • Eriksen M, Jensen DH, Tribler S, Holst JJ, Madsbad S, Krarup T. Reduction of insulinotropic properties of GLP-1 and GIP after glucocorticoid-induced insulin resistance. Diabetologia. 2015 May;58(5):920-8. doi: 10.1007/s00125-015-3522-y. Epub 2015 Mar 9.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Thure Krarup, dr. med.

    Bispebjerg Hospital

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 7, 2014

First Posted

September 10, 2014

Study Start

July 1, 2009

Primary Completion

June 1, 2014

Last Updated

September 10, 2014

Record last verified: 2014-09

Locations