Prospective Influence of Bedtime Insulin Glargine on Mobilization and Function of Endothelial Progenitor Cells - Full Text View

Purpose

In this trial, it will be studied whether early addition of the long acting insulin analogue Glargine is capable of increasing the number and differentiation of endothelial progenitor cells (EPC) in patients with type 2 diabetes, which can be seen as a marker of vascular regenerative potential and cardiovascular risk. In addition, the effect of Glargine on microvascular function will be studied. This will be done using laser Doppler measurements of the skin; in addition, MRI of the heart will be performed which is capable of quantifying the perfusion reserve of the myocardium and additional functional aspects of ventricular function. A beneficial effect of early addition of bedtime Glargine on EPC and vascular as well as myocardial function in this study might argue for a change in the therapeutic approach in type 2 diabetes and possibly improve the cardiovascular outcome in patients affected.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: Insulin Glargin Drug: Human Insulin	Phase IV

MedlinePlus related topics:

Diabetes

ChemIDplus related topics:

Insulin Insulin glargine Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Official Title:	Prospective Influence of Bedtime Insulin Glargine on Mobilization and Function of Endothelial Progenitor Cells in Patients With Type 2 Diabetes: a Partially Double-Blind, Randomized, Three-Arm Unicenter Study

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:

Change of number of circulating EPC 4 weeks after start of therapy compared to baseline as detected by FACS analysis [ Time Frame: 4 weaks of treatment ]

Secondary Outcome Measures:

Change of number of circulating EPC 4 as detected by in vitro outgrowth [ Time Frame: 4 weeks, 4 months ]
Skin microvascular function (as measured by laser Doppler perfusion upon heat stimulation) [ Time Frame: 4 months ]
Myocardial function and myocardial perfusion reserve as measured by MRI [ Time Frame: 4 months ]
Intima-Media-Thickness [ Time Frame: 4 months ]
Long-term Glucose control (HbA1c) [ Time Frame: 4 weeks, 4 months ]
Short-term Glucose control (fasting glucose) [ Time Frame: 4 weeks, 4 months ]
Markers of inflammation and vascular risk in diabetes [ Time Frame: 4 weeks, 4 months ]

Study Start Date:	August 2007
Estimated Study Completion Date:	March 2010

Arms	Assigned Interventions
1: No Intervention
2: Experimental	Drug: Insulin Glargin Titration of bedtime insulin glargin aiming at normal morning fasting glucose
3: Active Comparator	Drug: Human Insulin Titration of bedtime human insulin aiming at normal morning fasting glucose

Eligibility

Ages Eligible for Study:	35 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 Diabetes
Oral antidiabetic therapy
Age 35 - 70
6,5%< HbA1c ≤ 9%
Ability of subject to understand character and individual consequences of clinical trial
Written informed consent must be available before enrollment in the trial
For women with childbearing potential, adequate contraception (Pearl Index < 1%, e.g. birth control pill) and negative blood pregnancy test
6,5%< HbA1c ≤ 9%
Ability of subject to understand character and individual consequences of clinical trial
Written informed consent must be available before enrollment in the trial
For women with childbearing potential, adequate contraception (Pearl Index < 1%, e.g. birth control pill) and negative blood pregnancy test

Exclusion Criteria:

MODY
Malignant disease
Hematopoietic disorders
Impairment of renal function (Serum creatinine > 1,5mg/dl)
autoimmune disease
treatment with immunosuppressive drugs
Psychiatric disease
Myocardial ischemia during previous 6 month
Acute coronary syndrome
pAVK IIb, III, IV (Fontaine-Ratschow)
Erythropoietin treatment
Glitazone treatment during two weeks before inclusion
Insulin treatment during two weeks before inclusion
Pregnancy and lactation
History of hypersensitivity to the investigational product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational product
participation in other clinical trials and observation period of competing trials, respectively
No subject will be allowed to enroll in this trial more than once.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523393

Contacts


Contact: Per M Humpert, Dr.	+49 6221 56 ext 8027	per.humpert@med.uni-heidelberg.de

Contact: Dimitrios Oikonomou	+49 6221 56 ext 37944	dimitrios.oikonomou@med.uni-heidelberg.de

Locations


Germany
	University Clinics Heidelberg, Dept. Medicine1	Recruiting
	Heidelberg, Germany, 69120
	Contact: Dimitrios Oikonomou +49 6221 56 ext 37944 dimitrios.oikonomou@med.uni-heidelberg.de

Sponsors and Collaborators

University of Heidelberg

Investigators


Principal Investigator:	Per M Humpert, Dr.	University of Heidelberg, Dept. Medicine 1, Germany

More Information

Study ID Numbers:	2006-006573-24
First Received:	August 29, 2007
Last Updated:	August 29, 2007
ClinicalTrials.gov Identifier:	NCT00523393
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Metabolic Diseases

Diabetes Mellitus, Type 2

Glargine

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	University of Heidelberg
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00523393