Incretin Physiology Associated With Steroid Hormone Treatment

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Incretin Physiology and Beta-Cell Function Before and After Treatment With Steroid Hormone in Healthy Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00713440
• Other study ID #: ST-INK
• Status: Completed
• Phase: N/A
• First received: July 7, 2008
• Last updated: August 5, 2009
• Start date: July 2008
• Est. completion date: January 2009

Study information

• Verified date: August 2009
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of HealthDenmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Steroids
• Type 2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Denmark	Clinical Physiology Department; Glostrup Univesity Hospital	Glostrup	Region Hovedstaden

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incretin effect before and after dysregulation of glucose homeostasis using high calorie diet, physical inactivity and administration of adrenocortical steroids.		One year	No
Secondary	GLP-1 and GIP response curves		One year	No