Clinical trial NCT00523393: Prospective Influence of Bedtime Insulin Glargine on Mobilization and Function of Endothelial Progenitor Cells
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2007-08-31
Enrollment: 75
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Change of number of circulating EPC 4 weeks after start of therapy compared to baseline as detected by FACS analysis
timeFrame: 4 weaks of treatment
Secondary outcomes:
measure: Change of number of circulating EPC 4 as detected by in vitro outgrowth
timeFrame: 4 weeks, 4 months
measure: Skin microvascular function (as measured by laser Doppler perfusion upon heat stimulation)
timeFrame: 4 months
measure: Myocardial function and myocardial perfusion reserve as measured by MRI
timeFrame: 4 months
measure: Intima-Media-Thickness
timeFrame: 4 months
measure: Long-term Glucose control (HbA1c)
timeFrame: 4 weeks, 4 months
measure: Short-term Glucose control (fasting glucose)
timeFrame: 4 weeks, 4 months
measure: Markers of inflammation and vascular risk in diabetes
timeFrame: 4 weeks, 4 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Clinics Heidelberg, Dept. Medicine1
Study officials:
affiliation: University of Heidelberg, Dept. Medicine 1, Germany
name: Per M Humpert, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oikonomou D, Kopf S, von Bauer R, Djuric Z, Cebola R, Sander A, Englert S, Vittas S, Hidmark A, Morcos M, Korosoglou G, Nawroth PP, Humpert PM. Influence of insulin and glargine on outgrowth and number of circulating endothelial progenitor cells in type 2 diabetes patients: a partially double-blind, randomized, three-arm unicenter study. Cardiovasc Diabetol. 2014 Oct 11;13:137. doi: 10.1186/s12933-014-0137-4.