Effect of Glucagon-like Peptide 1 (GLP-1) on Microvascular Myocardial Function in Patients With Type 2 Diabetes.

NCT01931982 | Completed Phase 4 DMC

• 2 other identifiers: eudraCT: 2012-005013-382012-005013-38
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine if a GLP-1 agonist improves microvascular perfusion in the heart of patients with type 2 diabetes

Conditions

Type 2 Diabetes; Microvascular Dysfunction

Keywords

diabetes, GLP-1, Victoza, CFR, microvascular dysfunction

Outcome Measures

Primary Outcomes (1)

• Change in coronary flow reserve (CFR)

  CFR can be reliably assessed non-invasively by trans-thoracic Doppler flow echocardiography of the left anterior descending artery with a success rate of over 90% even in an obese population with a relative poor acoustic window. CFR is the ratio of flow during stress to during rest.

  CFR is measured at baseline and after 10 weeks of intervention

Secondary Outcomes (1)

• Change in Endothelial function:

  Endothelial function is measured at baseline and after 10 weeks of intervention

Other Outcomes (6)

• Changes in HbA1c

  Measurements at baseline and after 10 weeks of intervention

• Change in fasting C-peptide

  C-peptide is measured at baseline and after 10 weeks of intervention

• Change in fasting insulin

  Fasting insulin is measured at baseline and after 10 weeks of intervention

Study Arms (2)

victoza

ACTIVE COMPARATOR

The study is a cross over study. Patients randomised to start with victoza are treated with victoza for 10 weeks. After a wash out period of 2 weeks they cross over to 10 weeks of no treatment

Drug: Victoza

No treatment

NO INTERVENTION

Interventions

Victoza DRUG

victoza

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes on monotherapy with metformin or sulfonylurea or combination therapy of metformin and sulfonylurea.
• Age: 25-75 years
• BMI\>25 kg/m2
• HbA1c 6,0-10 %

You may not qualify if:

• Current treatment with insulin or Dipeptidyl peptidase IV inhibitor.
• Haemoglobin \< 6.5 mmol/l
• Documented significant stenosis of the left anterior descending artery (LAD) at coronary angiography or CT-angiography or regional dysfunction documented during dipyridamol stress-echocardiography. If stress test at baseline shows significant stenosis the patient will be excluded from the study.
• Allergy towards victoza ® (liraglutide ), Dipyridamol, Nitroglycerin or rescue medicine: Theophyllin
• Pregnancy
• Severe asthma
• Active cancer
• Severe co-morbidity with limited life-expectancy
• Estimated glomerular filtration rate (eGFR) \<60 (measured at baseline)
• Severe hepatic co-morbidity
• Chronic alcohol abuse
• Heart failure with a left ventricular ejection fraction \</= 45%
• Atrial fibrillation
• Chronic or previous acute pancreatitis
• Inflammatory bowel disease.

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Bispebjerg Hospital

Copenhagen, Capital Region, 2400, Denmark

Location

Related Publications (1)

• Faber R, Zander M, Pena A, Michelsen MM, Mygind ND, Prescott E. Effect of the glucagon-like peptide-1 analogue liraglutide on coronary microvascular function in patients with type 2 diabetes - a randomized, single-blinded, cross-over pilot study. Cardiovasc Diabetol. 2015 Apr 22;14:41. doi: 10.1186/s12933-015-0206-3.

  PMID: 25896352 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Mette Zander, consultant

  Department of Endocrinology, Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: August 30, 2013
• Study Start: May 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 25, 2014

Record last verified: 2014-06

Locations

DK (1)