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

Primary Purpose

Insulin Resistance, Deteriorated Glucose Homeostasis, Inactivity

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Steroid hormone
No intervention
Sponsored by
Glostrup University Hospital, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Insulin Resistance focused on measuring Incretin hormones, Glucagon, Insulin/c-peptide, Plasma glucose, Insulin resistance, Deteriorated glucose homeostasis, Inactivity

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Clinical Physiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

No intervention

Intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 7, 2010
Last Updated
June 20, 2011
Sponsor
Glostrup University Hospital, Copenhagen
Collaborators
University of Copenhagen, European Foundation for the Study of Diabetes
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1. Study Identification

Unique Protocol Identification Number
NCT01173978
Brief Title
Insulinotropic Effect of GIP and GLP-1 Before and After Reduced Glucose Tolerance
Official Title
Insulinotropic Effect of GIP and GLP-1 Before and After Reduced Glucose Induced by Steroid Treatment, Relative Physical Inactivity and High Calorie Diet
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Glostrup University Hospital, Copenhagen
Collaborators
University of Copenhagen, European Foundation for the Study of Diabetes

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Deteriorated Glucose Homeostasis, Inactivity
Keywords
Incretin hormones, Glucagon, Insulin/c-peptide, Plasma glucose, Insulin resistance, Deteriorated glucose homeostasis, Inactivity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Steroid hormone
Other Intervention Name(s)
Prednisolone
Intervention Description
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
Other
Intervention Name(s)
No intervention
Primary Outcome Measure Information:
Title
Insulinotropic effect of incretin hormones
Description
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 Outcome Measure Information:
Title
Plasma concentration of glucagon
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katrine B Hansen, MD
Organizational Affiliation
Glostrup University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Filip K Knop, MD,PhD
Organizational Affiliation
Gentofte University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tina Vilsbøll, MD,DmSc
Organizational Affiliation
Gentofte University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jens J Holst, MD, DmSc
Organizational Affiliation
University of Copenhagen
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Clinical Physiology
City
Glostrup
ZIP/Postal Code
DK-2600
Country
Denmark

12. IPD Sharing Statement

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

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