NCT01173978

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2010

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2010

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 3, 2010

Completed
Last Updated

June 21, 2011

Status Verified

July 1, 2010

Enrollment Period

3 months

First QC Date

June 7, 2010

Last Update Submit

June 20, 2011

Conditions

Insulin ResistanceDeteriorated Glucose HomeostasisInactivity

Keywords

Incretin hormonesGlucagonInsulin/c-peptidePlasma glucoseInsulin resistanceDeteriorated glucose homeostasisInactivity

Outcome Measures

Primary Outcomes (1)

  • Insulinotropic effect of incretin hormones

    Measurements of the insulinotropic effect of incretin hormones before and after 12 days intervention with steroid treatment, high calorie diet and relative physical inactivity

    12 days

Secondary Outcomes (1)

  • Plasma concentration of glucagon

    12 days

Study Arms (2)

No intervention

EXPERIMENTAL

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

Other: No intervention

Intervention

EXPERIMENTAL

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

Behavioral: Steroid hormone

Interventions

Steroid hormoneBEHAVIORAL

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

Also known as: Prednisolone
Intervention
No interventionOTHER
No intervention

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Physiology

Glostrup Municipality, DK-2600, Denmark

Location

MeSH Terms

Conditions

Insulin ResistanceSedentary Behavior

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Katrine B Hansen, MD

    Glostrup University Hospital

    PRINCIPAL INVESTIGATOR

  • Filip K Knop, MD,PhD

    Gentofte University Hospital

    STUDY CHAIR

  • Tina Vilsbøll, MD,DmSc

    Gentofte University Hospital

    STUDY CHAIR

  • Jens J Holst, MD, DmSc

    University of Copenhagen

    STUDY CHAIR

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

June 7, 2010

First Posted

August 3, 2010

Study Start

April 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

June 21, 2011

Record last verified: 2010-07

Locations

DK(1)