Incretin Physiology Associated With Steroid Hormone Treatment
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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:
|
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 |
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| Denmark | |
| 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 |
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 Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Anti-Inflammatory Agents Glucocorticoids Antineoplastic Agents, Hormonal |
ClinicalTrials.gov processed this record on May 21, 2013