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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Actrapid (human insulin)

• Registration Number: NCT00653510
• Lead Sponsor: University of Aarhus

Brief Summary

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.

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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-25
• Study First Submitted QC: 2008-04-02
• Study First Posted: 2008-04-07
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-17
• Last Update Posted: 2012-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Euglycemic	Actrapid (human insulin)	The patients will be examined with a blood glucose at around 5-7 mmol/L.
Hyperglycemic	Actrapid (human insulin)	The patients will be examined with a blood glucose at around 18-20 mmol/L

Primary Outcome Measures

Name	Time	Method
Metabolic changes	6 hours

Secondary Outcome Measures

Name	Time	Method
Left ventricular function	6 hours

Trial Locations

Locations (1)

Department M (Endocrinology and Diabetes), Aarhus University Hospital; 🇩🇰 Aarhus, Denmark