Incretin Physiology Associated With Steroid Hormone Treatment

This study has been completed.
Sponsor:
Information provided by:
Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT00713440
First received: July 7, 2008
Last updated: August 5, 2009
Last verified: August 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GLP-1 and GIP response curves [ Time Frame: One year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Glostrup University Hospital, Copenhagen

Additional 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
Study First Received: July 7, 2008
Last Updated: August 5, 2009
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 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
Acetaminophen
Methylprednisolone
Methylprednisolone Hemisuccinate
Gastric Inhibitory Polypeptide
Incretins
Hormones
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Methylprednisolone acetate
Prednisolone acetate
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Glucocorticoids
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on August 28, 2014