Insulinotropic Effect of GIP and GLP-1 Before and After Reduced Glucose Tolerance

NCT ID: NCT01173978

Last Updated: 2011-06-21

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-07-31

Brief Summary

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The incretin effect in patients with type two diabetes is reduced. The investigators have previously shown that it is possible to induce a defect in the incretin effect in healthy individuals. The purpose of this study is to evaluate the insulinotropic affect of the incretin hormones in healthy individuals before and after a deterioration of the glucose homeostasis.

Detailed Description

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The incretin effect in patients with type two diabetes is reduced. The investigators have previously shown that it is possible to induce a defect in the incretin effect in healthy individuals. The purpose of this study is to evaluate the insulinotropic affect of the incretin hormones in healthy individuals before and after a deterioration of the glucose homeostasis. The evaluation is done by infusing GIP, GLP-1 or saline during hyperglycemic clamps.

Conditions

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Insulin Resistance Deteriorated Glucose Homeostasis Inactivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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No intervention

Each participant is examined during a normal, active lifestyle, without any intervention: The examinations include an OGTT, a glucagon test, three hyperglycemic clamps with infusion of a)GLP-1; b)GIP; c)Nacl

Group Type EXPERIMENTAL

No intervention

Intervention Type OTHER

Intervention

Each participant is examined during a 12 days intervention.The examinations include an OGTT, a glucagon test, three hyperglycemic clamps with infusion of a)GLP-1; b)GIP; c)Nacl

Group Type EXPERIMENTAL

Steroid hormone

Intervention Type BEHAVIORAL

Steroid hormone: 37,5 mg of prednisolone; High energy diet: 130 % of recommended daily energy intake; Relative physical inactivity: no exercise and at least 8 hours of rest/day

Interventions

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Steroid hormone

Steroid hormone: 37,5 mg of prednisolone; High energy diet: 130 % of recommended daily energy intake; Relative physical inactivity: no exercise and at least 8 hours of rest/day

Intervention Type BEHAVIORAL

No intervention

Intervention Type OTHER

Other Intervention Names

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Prednisolone

Eligibility Criteria

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Inclusion Criteria

* Caucasians without type 2 diabetes mellitus
* Normal OGTT (75 g of glucose) according to WHO's criteria
* BMI 20-30
* Hemoglobin \> 8.0 mmol/l
* Informed consent

Exclusion Criteria

* Liver disease (ALAT \> 2 x normal level)
* Nephropathy (s-creatinin \> 130 µM or albuminuria)
* Relatives (parents/siblings) with T2DM
* Medical treatment witch cannot be stopped for 12 hours
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

European Foundation for the Study of Diabetes

OTHER

Sponsor Role collaborator

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Glostrup University Hospital

Principal Investigators

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Katrine B Hansen, MD

Role: PRINCIPAL_INVESTIGATOR

Glostrup University Hospital

Filip K Knop, MD,PhD

Role: STUDY_CHAIR

Gentofte University Hospital

Tina Vilsbøll, MD,DmSc

Role: STUDY_CHAIR

Gentofte University Hospital

Jens J Holst, MD, DmSc

Role: STUDY_CHAIR

University of Copenhagen

Locations

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Department of Clinical Physiology

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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DYS-CLAMP

Identifier Type: -

Identifier Source: org_study_id

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