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

March 25, 2008
September 17, 2012
March 2008
November 2010   (final data collection date for primary outcome measure)
Metabolic changes [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00653510 on ClinicalTrials.gov Archive Site
Left ventricular function [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Metabolic Effects of Acute Hyperglycemia in Patients With Type 2 Diabetes
The Effect of Acute Hyperglycemia on Cardiac Output, Amino Acid, Lipid and Glucose Metabolism 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Type 2 Diabetes Mellitus
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: Euglycemic
    The patients will be examined with a blood glucose at around 5-7 mmol/L.
    Intervention: Drug: Actrapid (human insulin)
  • Experimental: Hyperglycemic
    The patients will be examined with a blood glucose at around 18-20 mmol/L
    Intervention: Drug: Actrapid (human insulin)
Nielsen TS, Kampmann U, Nielsen RR, Jessen N, Orskov L, Pedersen SB, Jørgensen JO, Lund S, Møller N. Reduced mRNA and protein expression of perilipin A and G0/G1 switch gene 2 (G0S2) in human adipose tissue in poorly controlled type 2 diabetes. J Clin Endocrinol Metab. 2012 Jul;97(7):E1348-52. doi: 10.1210/jc.2012-1159. Epub 2012 Apr 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
40 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00653510
UK-M20070267
No
University of Aarhus
University of Aarhus
  • Aarhus University Hospital
  • Regionshospitalet Silkeborg
Principal Investigator: Niels Moeller, Professor Department M (Endocrinology and diabetes), Aarhus University Hospital, Nørrebrogade 44, 8000 Århus C, Denmark
University of Aarhus
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP