Prospective Influence of Bedtime Insulin Glargine on Mobi... | NCT00523393

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

NCT00523393

Sponsor

Heidelberg University

Status

Unknown status

Last Update Posted

Feb 13, 2009Estimated

Enrollment

75Estimated

Phase

Phase 4

Conditions

Type 2 Diabetes

Interventions

Insulin Glargin
Human Insulin

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Dec 2009Estimated

Completion Date

May 2010Estimated

First Submitted Date

Aug 29, 2007

First Submission Date that Met QC Criteria

Aug 29, 2007

First Posted Date

Aug 31, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2009

Last Update Posted Date

Feb 13, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Label	Type	Intervention Names
1	No Intervention
2	Experimental	Drug: Insulin Glargin
3	Active Comparator	Drug: Human Insulin

Name	Type	Description	Arm Group Labels	Other Names
Insulin Glargin	Drug	Titration of bedtime insulin glargin aiming at normal morning fasting glucose	2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Change of number of circulating EPC 4 as detected by in vitro outgrowth		4 weeks, 4 months
Skin microvascular function (as measured by laser Doppler perfusion upon heat stimulation)		4 months

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Per M Humpert, Dr.	Contact	+49 6221 56	8027	per.humpert@med.uni-heidelberg.de
Dimitrios Oikonomou	Contact	+49 6221 56	37944	dimitrios.oikonomou@med.uni-heidelberg.de

Overall Officials

Name	Affiliation	Role
Per M Humpert, Dr.	University of Heidelberg, Dept. Medicine 1, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Clinics Heidelberg, Dept. Medicine1	Recruiting	Heidelberg		69120	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25300286	Derived	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.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones