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

Optimized Glycemic Control in Type 2 Diabetics With Heart Failure:Effect on Left Ventricular Function and Skeletal Muscle

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01213784
Acronym
HFDM
Enrollment
40
Registered
2010-10-04
Start date
2010-09-30
Completion date
2012-11-30
Last updated
2015-03-06

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

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.

Interventions

OTHERall 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%

Sponsors

The Danish Diabetes Association
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Left ventricular function4 monthLeft ventricular function will be evaluated using echocardiografi measuring: \- 2D Ejection fraction (using an ultrasound agent), global and regional tissue velocity, Strain / strain rate - all measures done during rest and dobutamin stress test.

Secondary

MeasureTime frameDescription
hormonal and metabolic profile4 monthbloodsamples
6-minutes hall walk test4 monthusing a hall walk protocol
Exercise capacity and peak oxygen consumption4 monthusing a treadmill test and continues oxygen consumption measurement
Muscle strength and mass4 monthmuscle strength: hand grip test

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026