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CompletedNCT01173978Updated Jun 21, 2011

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

An interventional study of Steroid hormone and No intervention in Insulin Resistance, Deteriorated Glucose Homeostasis and Inactivity, sponsored by Glostrup University Hospital, Copenhagen. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-21.

Sponsored by Glostrup University Hospital, Copenhagen · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Male
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Insulin Resistance
  • Deteriorated Glucose Homeostasis
  • Inactivity

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Keywords

  • Incretin hormones
  • Glucagon
  • Insulin/c-peptide
  • Plasma glucose
  • Insulin resistance
  • Deteriorated glucose homeostasis
  • Inactivity
03

In context

Insulin Resistance

1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.

This study's enrollment of 10 is below the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

Glostrup University Hospital, Copenhagen is the lead sponsor of 104 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    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

    Other: No intervention

  • Experimental
    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

    Behavioral: Steroid hormone

Interventions

  • BehavioralSteroid 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

    Also known as: Prednisolone

  • OtherNo intervention
06

What researchers measure

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

    Time frame: 12 days

Secondary outcomes

  1. Plasma concentration of glucagon

    Measurements of plasma concentration of glucagon before and after 12 days intervention with steroid treatment, high calorie diet and relative physical inactivity

    Time frame: 12 days

07

Study locations

1 site
  • Department of Clinical Physiology
    Glostrup, DK-2600, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01173978
Lead sponsor
Glostrup University Hospital, Copenhagen
Collaborators
University of Copenhagen, European Foundation for the Study of Diabetes
First posted
Aug 3, 2010
Start date
Apr 2010
Primary completion
Jul 2010
Completion
Jul 2010
Last update
Jun 21, 2011

Study contacts

Katrine B Hansen, MD
principal investigator · Glostrup University Hospital
Filip K Knop, MD,PhD
study chair · Gentofte University Hospital
Tina Vilsbøll, MD,DmSc
study chair · Gentofte University Hospital
Jens J Holst, MD, DmSc
study chair · University of Copenhagen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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