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Completed

NCT Number: NCT00653510

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

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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department M (Endocrinology and Diabetes), Aarhus University Hospital

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Actrapid (human insulin)

Drug

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.

Primary outcomes

  1. Metabolic changes

    Time frame: 6 hours

Secondary outcomes

  1. Left ventricular function

    Time frame: 6 hours

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Regionshospitalet Silkeborg

Registry information

Official study title

The Effect of Acute Hyperglycemia on Cardiac Output, Amino Acid, Lipid and Glucose Metabolism in Patients With Type 2 Diabetes

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 7, 2008
Registry last updated
Sep 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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