The Metabolic Effects of Acute Hyperglycemia in Patients With Type 2 Diabetes - Full Text View

Sponsors and Collaborators:	University of Aarhus Aarhus University Hospital Silkeborg Hospital, Denmark
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00653510

Purpose

The purpose of the study is to characterize the changes in amino acid, lipid and glucose metabolism in patients with type 2 diabetes exposed to acute hyperglycemia. Moreover we wish to assess the effect of acute hyperglycemia on cardiac output.

Condition	Intervention
Type 2 Diabetes Mellitus	Drug: Actrapid (human insulin)

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Dextrose Amino acids, branched-chain Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:	The Effect of Acute Hyperglycemia on Cardiac Output, Amino Acid, Lipid and Glucose Metabolism in Patients With Type 2 Diabetes

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

Metabolic changes [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Left ventricular function [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	March 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental On day one the patients will receive glucose and insulin in order to reach a blood sugar around 18 and 20 mmol/L and on day two the patients will receive glucose and insulin in order to have a blood sugar around 5 and 7 mmol/L. On both days amino acid, lipid and glucose metabolism will be assessed by means of whole body isotope dilution.	Drug: Actrapid (human insulin) On day one the patients will receive glucose and insulin in order to reach a blood sugar around 18 and 20 mmol/L and on day two the patients will receive glucose and insulin in order to have a blood sugar around 5 and 7 mmol/L. On both days amino acid, lipid and glucose metabolism will be assessed by means of whole body isotope dilution.

Detailed Description:

Cardiovascular disease is the main cause of death in modern Western societies. Obesity, diabetes and the metabolic syndrome are the main risk factors for cardiovascular disease. People with type 2 diabetes and no history of heart disease have a risk of myocardial infarction similar to the risk in non-diabetic patients with known heart disease.

However, the causal relationship between obesity, diabetes and cardiovascular disease is unclear. Insulin resistance leads to many metabolic abnormalities, including high circulating levels of free fatty acids (FFA). FFA induces insulin resistance and may lead to beta cell failure. In addition FFA may directly worsen the metabolic and electrochemical performance of the working heart. Moreover it is still unclear how acute hyperglycemia affects cardiac output.

In this study our purpose is to characterize the changes in amino acid, lipid and glucose metabolism in patients with type 2 diabetes exposed to acute hyperglycemia (blood glucose between 18 and 20 mmol/L) compared to the amino acid, lipid and glucose metabolism at a normal glucose level (blood glucose between 5 and 7 mmol/L). The results from the patients with type 2 diabetes will be compared with results from healthy controls examined in a fasting basal state. The patients must not suffer from any kind of serious heart disease and should be treated with insulin.

Moreover we wish to compare cardiac output at high and normal blood glucose levels, respectively. Cardiac output will primarily be assessed by doppler echocardiography.

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Written consent
Age 40-75 years old
BMI between 22 and 35
Type 2 diabetes treated with insulin (< 60 IE/day)

Exclusion Criteria:

Severe disease
Severe cardiac disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653510

Locations

Denmark
Department M (Endocrinology and Diabetes), Aarhus University Hospital
Aarhus, Denmark, 8000

Sponsors and Collaborators

University of Aarhus

Aarhus University Hospital

Silkeborg Hospital, Denmark

Investigators

Principal Investigator:

Niels Moeller, Professor

Department M (Endocrinology and diabetes), Aarhus University Hospital, Nørrebrogade 44, 8000 Århus C, Denmark

More Information

Responsible Party:	Department of Endocrinology M, Aarhus University Hospital ( Professor, MD, Niels Moeller )
Study ID Numbers:	UK-M20070267
Study First Received:	March 25, 2008
Last Updated:	April 2, 2008
ClinicalTrials.gov Identifier:	NCT00653510
Health Authority:	Denmark: Danish Dataprotection Agency; Denmark: The Regional Committee on Biomedical Research Ethics; Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:

Type 2 diabetes
Dysregulation
Metabolism
Cardiac output

Study placed in the following topic categories:

Metabolic Diseases
Hyperglycemia
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

ClinicalTrials.gov processed this record on January 16, 2009