Incretin Physiology Associated With Steroid Hormone Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-01-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Type 2 Diabetes Mellitus Steroids

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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1

10 healthy Caucasian subjects without family history of diabetes

Group Type EXPERIMENTAL

Oral glucose test (OGTT); isoglycaemic iv. clamp; liquid meal test; Gastric Emptying Rate; Prednisolone; Paracetamol

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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Prednisolone Paracetamol

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes