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

NCT01213784 | Completed Phase 2 DMC

• 1 other identifier: M20090047
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Left ventricular function

  Left 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.

  4 month

Secondary Outcomes (4)

• hormonal and metabolic profile

  4 month

• 6-minutes hall walk test

  4 month

• Exercise capacity and peak oxygen consumption

  4 month

• Muscle strength and mass

  4 month

Study Arms (2)

optimized diabetic control

EXPERIMENTAL

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

Other: all antidiabetic drugs will be appliable

control

NO INTERVENTION

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.

Interventions

all antidiabetic drugs will be appliable 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%

optimized diabetic control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead
• The Danish Diabetes Association: collaborator

Study Sites (1)

Dept. of cardiology, Aarhus university hospital Skejby

Aarhus, Central Jutland, 8200, Denmark

Location

Related Publications (1)

• 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.

  PMID: 27158520 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Heart Failure

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Roni R Nielsen, MD

  Dept. of cardiology, University hospital Aarhus Skejby

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2010
• First Posted: October 4, 2010
• Study Start: September 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 6, 2015

Record last verified: 2013-06

Locations

DK (1)