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

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University of Aarhus

Status and phase

Completed
Phase 2

Conditions

Type 2 Diabetes
Heart Failure

Treatments

Drug: insulin

Study type

Interventional

Funder types

Other

Identifiers

NCT01071772
M20080151

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

30 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

18 participants in 2 patient groups

euglycemia
Experimental group
Treatment:
Drug: insulin
hyperglycemia
Experimental group
Treatment:
Drug: insulin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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