Incretin Physiology Associated With Steroid Hormone Treatment

Not Applicable

Completed

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

• Registration Number: NCT00713440
• Lead Sponsor: Glostrup University Hospital, Copenhagen

Brief 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.

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

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-07
• Study First Submitted QC: 2008-07-09
• Study First Posted: 2008-07-11
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-05
• Last Update Posted: 2009-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Oral glucose test (OGTT); isoglycaemic iv. clamp; liquid meal test; Gastric Emptying Rate; Prednisolone; Paracetamol	10 healthy Caucasian subjects without family history of diabetes

Primary Outcome Measures

Name	Time	Method
Incretin effect before and after dysregulation of glucose homeostasis using high calorie diet, physical inactivity and administration of adrenocortical steroids.	One year

Secondary Outcome Measures

Name	Time	Method
GLP-1 and GIP response curves	One year

Trial Locations

Locations (1)

Clinical Physiology Department; Glostrup Univesity Hospital; 🇩🇰 Glostrup, Region Hovedstaden, Denmark