Incretin Physiology Associated With Steroid Hormone Treatment
|ClinicalTrials.gov Identifier: NCT00713440|
Recruitment Status : Completed
First Posted : July 11, 2008
Last Update Posted : August 6, 2009
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus Steroids||Other: Oral glucose test (OGTT); isoglycaemic iv. clamp; liquid meal test; Gastric Emptying Rate; Prednisolone; Paracetamol||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|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|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
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
- Incretin effect before and after dysregulation of glucose homeostasis using high calorie diet, physical inactivity and administration of adrenocortical steroids. [ Time Frame: One year ]
- GLP-1 and GIP response curves [ Time Frame: One year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00713440
|Clinical Physiology Department; Glostrup Univesity Hospital|
|Glostrup, Region Hovedstaden, Denmark, 2600|
|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|