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

Metabolic Substrate Modulation in Insulin Treated Diabetics With and Without Heart Failure: The Effect of Hyperglycemia on Left Ventricular Function and Exercise Capacity.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01071772

Acronym

METAMOD

Enrollment

Registered

2010-02-19

Start date

2009-04-30

Completion date

2010-07-31

Last updated

2011-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Type 2 Diabetes

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.

Interventions

DRUGinsulin

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Regional left ventricular function before and after maximum exercise(regional 2D tissue velocity and strain)	1-4 weeks

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026