The Effect of Hyperglycemia on LV Function and Exercise Capacity in Diabetics With and Without Heart Failure.

NCT01071772 | Completed Phase 2 DMC

• 1 other identifier: M20080151
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes and Heart Failure are diseases with high morbidity and increased risk of death. Former investigations has shown that diabetes worsens the prognosis of heart failure. However it is uncertain how short term diabetic dysregulation in type 2 diabetics affect cardiac function. Our hypothesis is that short term dysregulation affects left ventricular function and exercise capacity in insulin treated type 2 diabetics with and without heart failure. To elucidate this hypothesis diabetic patients with and without heart failure will be investigated after overnight state of either high or normal blood glucose levels on two separate occasions. Metabolic and hormonal parameters will be measured. Systolic and diastolic cardiac function will be assessed, exercise capacity and post exercise regional myocardial tissue velocity as well as 6 minutes walk test will be investigated on both occasions. The study will be a randomized cross-over design.

Conditions

Heart Failure; Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• 1: Cardiac systolic (EF by 2D and 3D echocardiography) and diastolic (e´/E and E/A) function before and after exercise.

  1-4 weeks

• Exercise capacity

  1-4 months

Secondary Outcomes (1)

• Regional left ventricular function before and after maximum exercise(regional 2D tissue velocity and strain)

  1-4 weeks

Study Arms (2)

euglycemia

EXPERIMENTAL

Drug: insulin

hyperglycemia

EXPERIMENTAL

Drug: insulin

Interventions

insulin DRUG

There will be used individual intravenous insulin (actrapid) infusion to prevent non-intended hyperglycemia.

euglycemia; hyperglycemia

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Either normal ejection fraction (EF) or heart failure (EF =\<45%)
• Insulin treated type 2

You may not qualify if:

• Forme stroke with significant physically or mentally disabilitating disorders
• advanced renal disease (creatinine levels \>220 mM)
• advanced lever disease (alanine aminotransferase \> 3 times over reference level).
• pregnancy
• other significant disabilitating disorders

Sponsors & Collaborators

• University of Aarhus: lead
• Danish Heart Foundation: collaborator
• Region midtjyllands sundhedsvidenskabelige forskningsfond: collaborator

Study Sites (1)

Department ofCardiology, Aarhus University Hospital, Skejby

Aarhus, Central Jutland, 8200, Denmark

Location

MeSH Terms

Conditions

Heart Failure; Diabetes Mellitus, Type 2

Interventions

Insulin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; 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

• Hans Erik Boedker, Prof, MD

  Dept. of cardiolgy, Aarhus University hospital, Skejby. Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 16, 2010
• First Posted: February 19, 2010
• Study Start: April 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: June 9, 2011

Record last verified: 2011-06

Locations

DK (1)