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| Sponsored by: |
Glostrup University Hospital,Copenhagen |
|---|---|
| Information provided by: | Glostrup University Hospital,Copenhagen |
| ClinicalTrials.gov Identifier: | NCT00713440 |
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: | Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
| Official Title: | Incretin Physiology and Beta-Cell Function Before and After Treatment With Steroid Hormone in Healthy Individuals |
| Estimated Enrollment: | 10 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | July 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
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:
Exclusion Criteria:
Contacts and Locations| Contact: Katrine B Hansen, MD | +45 40509942 | kabaha01@glo.regionh.dk |
| Contact: Filip K Knop, MD; Ph-D | filipknop@dadlnet.dk |
| Denmark, Region Hovedstaden | |
| Clinical Physiology Department; Glostrup Univesity Hospital | Recruiting |
| Glostrup, Region Hovedstaden, Denmark, 2600 | |
| Contact: Katrine B Hansen, MD +45 405099042 kabaha01@glo.regionh.dk | |
| Study Director: | Filip K Knop, MD; Ph-D | Gentofte University Hospital |
| Study Chair: | Tina Vilsboll, MD; Ph-D, DMSc | Herlev University Hospital |
| 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
| Responsible Party: | Glostrup University Hospital ( Katrine Bagge Hansen, MD ) |
| Study ID Numbers: | ST-INK |
| Study First Received: | July 7, 2008 |
| Last Updated: | July 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00713440 History of Changes |
| Health Authority: | Denmark: National Board of Health; Denmark: The Danish National Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency |
|
Incretin Effect Steroids Glucagon-Like Peptide 1 Gastric Inhibitory Peptide |
Glucose-dependent Insulinotropic Polypeptide Insulin C-peptide Glucagon |
|
Anti-Inflammatory Agents Gastric Inhibitory Polypeptide Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Healthy Neuroprotective Agents Hormones Insulin Analgesics Metabolic Disorder Acetaminophen Methylprednisolone Hemisuccinate |
Metabolic Diseases Antineoplastic Agents, Hormonal Glucagon Diabetes Mellitus Methylprednisolone acetate Endocrine System Diseases Glucocorticoids Glucagon-Like Peptide 1 Analgesics, Non-Narcotic Prednisolone Diabetes Mellitus, Type 2 Incretins Endocrinopathy Peripheral Nervous System Agents Glucose Metabolism Disorders |
|
Anti-Inflammatory Agents Gastric Inhibitory Polypeptide Antineoplastic Agents Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Neuroprotective Agents Hormones Sensory System Agents Therapeutic Uses Analgesics Acetaminophen Methylprednisolone Hemisuccinate |
Metabolic Diseases Antineoplastic Agents, Hormonal Gastrointestinal Agents Diabetes Mellitus Methylprednisolone acetate Endocrine System Diseases Protective Agents Glucocorticoids Pharmacologic Actions Autonomic Agents Analgesics, Non-Narcotic Prednisolone Diabetes Mellitus, Type 2 Incretins Peripheral Nervous System Agents |
