The Metabolic Effects of Acute Hyperglycemia in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Aarhus University Hospital
Regionshospitalet Silkeborg
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00653510
First received: March 25, 2008
Last updated: September 17, 2012
Last verified: September 2012
  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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Effect of Acute Hyperglycemia on Cardiac Output, Amino Acid, Lipid and Glucose Metabolism in Patients With Type 2 Diabetes

Resource links provided by NLM:


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 ]

Enrollment: 18
Study Start Date: March 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Euglycemic
The patients will be examined with a blood glucose at around 5-7 mmol/L.
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.
Experimental: Hyperglycemic
The patients will be examined with a blood glucose at around 18-20 mmol/L
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Regionshospitalet Silkeborg
Investigators
Principal Investigator: Niels Moeller, Professor Department M (Endocrinology and diabetes), Aarhus University Hospital, Nørrebrogade 44, 8000 Århus C, Denmark
  More Information

No publications provided by University of Aarhus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00653510     History of Changes
Other Study ID Numbers: UK-M20070267
Study First Received: March 25, 2008
Last Updated: September 17, 2012
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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014