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

University of Aarhus

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Actrapid (human insulin)

Study type: Interventional

Funder types: Other

Identifiers

NCT00653510

UK-M20070267

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Euglycemic

Experimental group

Description:

The patients will be examined with a blood glucose at around 5-7 mmol/L.

Treatment:

Drug: Actrapid (human insulin)

Hyperglycemic

Experimental group

Description:

The patients will be examined with a blood glucose at around 18-20 mmol/L

Treatment:

Drug: Actrapid (human insulin)