Prospective Influence of Bedtime Insulin Glargine on Mobilization and Function of Endothelial Progenitor Cells

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00523393
• Other study ID #: 2006-006573-24
• Status: Recruiting
• Phase: Phase 4
• First received: August 29, 2007
• Last updated: February 12, 2009
• Start date: August 2007
• Est. completion date: May 2010

Study information

• Verified date: February 2009
• Source: Heidelberg University
• Contact: Per M Humpert, Dr.
• Phone: +49 6221 56
• Email: per.humpert[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: May 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Insulin Glargin
Titration of bedtime insulin glargin aiming at normal morning fasting glucose
• Human Insulin
Titration of bedtime human insulin aiming at normal morning fasting glucose

Locations

Country	Name	City	State
Germany	University Clinics Heidelberg, Dept. Medicine1	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of number of circulating EPC 4 weeks after start of therapy compared to baseline as detected by FACS analysis		4 weaks of treatment	No
Secondary	Change of number of circulating EPC 4 as detected by in vitro outgrowth		4 weeks, 4 months	No
Secondary	Skin microvascular function (as measured by laser Doppler perfusion upon heat stimulation)		4 months	No
Secondary	Myocardial function and myocardial perfusion reserve as measured by MRI		4 months	No
Secondary	Intima-Media-Thickness		4 months	No
Secondary	Long-term Glucose control (HbA1c)		4 weeks, 4 months	No
Secondary	Short-term Glucose control (fasting glucose)		4 weeks, 4 months	No
Secondary	Markers of inflammation and vascular risk in diabetes		4 weeks, 4 months	No