Optimized Glycemic Control in Heart Failure Patients With DM2:"Effect on Left Ventricular Function and Skeletal Muscle"

NCT ID: NCT01213784

Last Updated: 2015-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-11-30

Brief Summary

The investigators wish to investigate wether a more strict diabetic control improves cardiac function, muscle strength, exercise capacity and decreases symptoms.

The investigators hypothesis is that improving the glycemic control in suboptimized diabetics with heart failure will improve cardiac performance, muscle strength, exercise capacity and decrease symptoms.

Conditions

Type 2 Diabetes; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

optimized diabetic control

each participant will be assigned to be optimized in a dedicated diabetic clinic

Group Type: EXPERIMENTAL

all antidiabetic drugs will be appliable

Intervention Type: OTHER

We expect all participants to be set on insulin during the intervention, however all types of insulin and other antidiabetics can be used goal: Hba1c lower than 7,5%

control

participants will be assigned to follow what ever control they were in before the study and not to change any antidiabetic treatment during the interventions period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

all antidiabetic drugs will be appliable

We expect all participants to be set on insulin during the intervention, however all types of insulin and other antidiabetics can be used goal: Hba1c lower than 7,5%

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Ejection fraction =<45%
• Diabetes
• Hba1c =>7,5%
• In anticongestive treatment
• NYHA class 2-4

Exclusion Criteria

• Severe angina (CCS 3-4)
• Hemodynamic significant heart valve disease
• Congenital heart disease
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Danish Diabetes Association

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roni R Nielsen, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of cardiology, University hospital Aarhus Skejby

Locations

Dept. of cardiology, Aarhus university hospital Skejby

Aarhus, Central Jutland, Denmark

Countries

Denmark

References

Nielsen R, Wiggers H, Thomsen HH, Bovin A, Refsgaard J, Abrahamsen J, Moller N, Botker HE, Norrelund H. Effect of tighter glycemic control on cardiac function, exercise capacity, and muscle strength in heart failure patients with type 2 diabetes: a randomized study. BMJ Open Diabetes Res Care. 2016 Apr 29;4(1):e000202. doi: 10.1136/bmjdrc-2016-000202. eCollection 2016.

Reference Type: DERIVED

PMID: 27158520 (View on PubMed)

Other Identifiers

M20090047

Identifier Type: -

Identifier Source: org_study_id