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

NCT00653510 | Completed

• 1 other identifier: UK-M20070267
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes; Dysregulation; Metabolism; Cardiac output

Outcome Measures

Primary Outcomes (1)

• Metabolic changes

  6 hours

Secondary Outcomes (1)

• Left ventricular function

  6 hours

Study Arms (2)

Euglycemic

EXPERIMENTAL

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

Drug: Actrapid (human insulin)

Hyperglycemic

EXPERIMENTAL

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

Drug: Actrapid (human insulin)

Interventions

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.

Euglycemic; Hyperglycemic

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written consent
• Age 40-75 years old
• BMI between 22 and 35
• Type 2 diabetes treated with insulin (\< 60 IE/day)

You may not qualify if:

• Severe disease
• Severe cardiac disease

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Regionshospitalet Silkeborg: collaborator

Study Sites (1)

Department M (Endocrinology and Diabetes), Aarhus University Hospital

Aarhus, Aarhus, 8000, Denmark

Location

Related Publications (2)

• Nielsen R, Norrelund H, Kampmann U, Botker HE, Moller N, Wiggers H. Effect of acute hyperglycemia on left ventricular contractile function in diabetic patients with and without heart failure: two randomized cross-over studies. PLoS One. 2013;8(1):e53247. doi: 10.1371/journal.pone.0053247. Epub 2013 Jan 8.

  PMID: 23308171 DERIVED

• Nielsen TS, Kampmann U, Nielsen RR, Jessen N, Orskov L, Pedersen SB, Jorgensen JO, Lund S, Moller 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.

  PMID: 22535977 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Niels Moeller, Professor

  Department M (Endocrinology and diabetes), Aarhus University Hospital, Nørrebrogade 44, 8000 Århus C, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2008
• First Posted: April 7, 2008
• Study Start: March 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: September 18, 2012

Record last verified: 2012-09

Locations

DK (1)