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Incretin Physiology Associated With Steroid Hormone Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00713440
First Posted: July 11, 2008
Last Update Posted: August 6, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Glostrup University Hospital, Copenhagen
  Purpose
The purpose of this study is to evaluate whether the reduced incretin effect and the paradoxical glucagon responses during oral glucose ingestion and isoglycaemic iv glucose infusion observed in patients with type 2 diabetes are causes (non-inducible in lean healthy subjects without family history of diabetes) or consequences (inducible) of the diabetic state.

Condition Intervention
Type 2 Diabetes Mellitus Steroids Other: Oral glucose test (OGTT); isoglycaemic iv. clamp; liquid meal test; Gastric Emptying Rate; Prednisolone; Paracetamol

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Incretin Physiology and Beta-Cell Function Before and After Treatment With Steroid Hormone in Healthy Individuals

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incretin effect before and after dysregulation of glucose homeostasis using high calorie diet, physical inactivity and administration of adrenocortical steroids. [ Time Frame: One year ]

Secondary Outcome Measures:
  • GLP-1 and GIP response curves [ Time Frame: One year ]

Enrollment: 10
Study Start Date: July 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
10 healthy Caucasian subjects without family history of diabetes
Other: Oral glucose test (OGTT); isoglycaemic iv. clamp; liquid meal test; Gastric Emptying Rate; Prednisolone; Paracetamol

OGTT: The test is performed with 50 g of glucose deluded in 300 ml. of water. Isoglycaemic iv. clamp: Iv glucose infusion mimicking the glucose response curve of the OGTT.

Liquid Meal Test: The test is performed with 100g of formula milk in 300 ml. of water.

Gastric Emptying Rate: Paracetamol absorption test. Adrenocortical Steroids: Use of 37,5 mg./day of prednisolone during 10 days

Other Names:
  • Prednisolone
  • Paracetamol

Detailed Description:

The incretin effect is severely reduced in patients with type 2 diabetes. This pathophysiological trait is accompanied by an almost abolished insulinotropic effect of the incretin hormone glucose-dependent insulinotropic polypeptide (GIP) and a reduced insulinotropic potency of the other incretin hormone glucagon-like peptide-1 (GLP-1). Furthermore, recent studies suggest that hypersecretion of glucagon during oral glucose ingestion, as opposed to a normal suppression of glucagon during isoglycaemic intravenous (iv) administered glucose, further attenuates the incretin effect in patients with type 2 diabetes.

However, it remains unclear whether the severely reduced incretin effect and its accompanying pathophysiological traits characterizing patients with type 2 diabetes can be induced temporarily in healthy subjects by a short period of glucose homeostatic dysregulation.

In this study the incretin effect will be measured using 50-g oral glucose tolerance test and isoglycaemic iv glucose infusion and meal test in 10 healthy Caucasian subjects without family history of diabetes before and after dysregulation of glucose homeostasis using high calorie diet, physical inactivity and administration of adrenocortical steroids

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Caucasians without Type 2 or Type 1 Diabetes
  • Normal OGTT (75 g of glucose) according to WHO criteria
  • Normal hemoglobin
  • Normal blood pressure

Exclusion Criteria:

  • Liver disease
  • Kidney disease
  • Relatives (parents/siblings) with type 2 diabetes
  • Pregnancy
  • Contra-indications to treatment with adrenocortical steroids
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00713440


Locations
Denmark
Clinical Physiology Department; Glostrup Univesity Hospital
Glostrup, Region Hovedstaden, Denmark, 2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
Study Director: Filip K Knop, MD; Ph-D Gentofte University Hospital
Study Chair: Tina Vilsboll, MD; Ph-D, DMSc University of Copenhagen
Principal Investigator: Katrine B Hansen, MD Glostrup University Hospital
Study Chair: Steen Larsen, MD; DMSc Glostrup University Hospital
Study Chair: Jens J Holst, Professor: DMSc University of Copenhagen
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Katrine Bagge Hansen, MD, Glostrup University Hospital
ClinicalTrials.gov Identifier: NCT00713440     History of Changes
Other Study ID Numbers: ST-INK
First Submitted: July 7, 2008
First Posted: July 11, 2008
Last Update Posted: August 6, 2009
Last Verified: August 2009

Keywords provided by Glostrup University Hospital, Copenhagen:
Incretin Effect
Steroids
Glucagon-Like Peptide 1
Gastric Inhibitory Peptide
Glucose-dependent Insulinotropic Polypeptide
Insulin
C-peptide
Glucagon

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hormones
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Glucagon
Gastric Inhibitory Polypeptide
Prednisolone acetate
Methylprednisolone acetate
Acetaminophen
Incretins
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Analgesics, Non-Narcotic