Insulinotropic Effect of GLP-1 and GIP After Dexamethasone

NCT ID: NCT02235584

Last Updated: 2014-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Brief Summary

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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.

Detailed Description

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In this study we are going to examine the insulinotropic properties of GLP-1 and GIP before and after the development of insulin resistance and/or glucose intolerance.The insulinotropic properties of GLP-1 and GIP are greatly reduced in type 2 diabetes.

Since the development of type 2 diabetes is preceded by insulin resistance and glucose intolerance we wanted to examine the insulinotropic properties of GLP-1 and GIP in the early stages of type 2 diabetes.

To do this, we want to induce insulin resistance and/or glucose intolerance. This is achieved by 5 days of treatment with dexamethasone.

Subjects are studied on 4 different days in randomized order, with an oral glucose tolerance test (OGTT) and glucose clamps + infusions of GLP-1, GIP and NaCl before and immediately after 5 days treatment with dexamethasone, 2mg bid. On day 1, 2 and 3 after the 5 days of dexamethasone, 2mg dexamethasone was given in the afternoon after the tests to ensure unchanged insulin resistance

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Dexamethasone

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

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Dexamethasone are given dexamethasone tablets of 2mg twice daily.

Interventions

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Dexamethasone

Dexamethasone are given dexamethasone tablets of 2mg twice daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Carsten Dirksen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thure Krarup, dr. med.

Role: STUDY_DIRECTOR

Bispebjerg Hospital

Locations

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Bispebjerg University Hospital

Copenhagen NV, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 25748606 (View on PubMed)

Other Identifiers

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H-D-2009-070

Identifier Type: -

Identifier Source: org_study_id

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