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

This study has been completed.
Sponsor:
Collaborators:
University of Copenhagen
European Foundation for the Study of Diabetes
Information provided by:
Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01173978
First received: June 7, 2010
Last updated: June 20, 2011
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention
Insulin Resistance
Deteriorated Glucose Homeostasis
Inactivity
 Behavioral: Steroid hormone
Other: No intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • Insulinotropic effect of incretin hormones [ Time Frame: 12 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 days ] [ Designated as safety issue: No ]
    Measurements of plasma concentration of glucagon before and after 12 days intervention with steroid treatment, high calorie diet and relative physical inactivity


Enrollment: 10
Study Start Date: April 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
-
Other Name: 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
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
Other Name: Prednisolone

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173978

Locations
Denmark
Department of Clinical Physiology
Glostrup, Denmark, DK-2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
University of Copenhagen
European Foundation for the Study of Diabetes
Investigators
Principal Investigator: Katrine B Hansen, MD Glostrup University Hospital
Study Chair: Filip K Knop, MD,PhD Gentofte University Hospital
Study Chair: Tina Vilsbøll, MD,DmSc Gentofte University Hospital
Study Chair: Jens J Holst, MD, DmSc Faculty of Health Sciences, University of Copenhagen
  More Information

No publications provided

Responsible Party: Katrine Bagge Hansen. MD, Glostrup University Hospital
ClinicalTrials.gov Identifier: NCT01173978     History of Changes
Other Study ID Numbers: DYS-CLAMP
Study First Received: June 7, 2010
Last Updated: June 20, 2011
Health Authority: Denmark: National Board of Health
Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Glostrup University Hospital, Copenhagen:
Incretin hormones
Glucagon
Insulin/c-peptide
Plasma glucose
 Insulin resistance
Deteriorated glucose homeostasis
Inactivity

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hormones
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Methylprednisolone acetate
Prednisolone acetate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
 Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Glucocorticoids
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 22, 2013