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Trial record 72 of 236 for:    stem cell diabetes

Effect of Sitagliptin on Endothelial Progenitor Cells

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00968006
Recruitment Status : Completed
First Posted : August 28, 2009
Last Update Posted : April 5, 2010
Information provided by:
University of Padova

Brief Summary:

Endothelial progenitor cells (EPCs) are involved in cardiovascular homeostasis, through angiogenesis and endothelial healing. Diabetic patients have a high risk of cardiovascular events and low levels of circulating EPCs.

Sitagliptin is an oral DPP-IV antagonist, approved for the treatment of type 2 diabetes. It increases the bioavailability of endogenous incretins, thus improving insulin and glucagon secretion. SDF-1, one of the major EPC regulators, is also a substrate of DPP-IV. This study tests the hypothesis that sitagliptin increases the levels of circulating EPCs in type 2 diabetic patients.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Sitagliptin Phase 4

Detailed Description:

Diabetic patients suffer an elevated wirk of cardiovascular events, which strongly impact on morbidity and mortality. The mechanisms that lead to cardiovascular disease in diabetes include alterations in the endothelial layer, due to hyperglycemia, oxidative stress and other associated abnormalities. Endothelial progenitor cells (EPCs) are bone marrow-derived cells involved in endothelial repair after injury, and they have been found to be reduced in diabetic patients. Thus, reduced EPCs in diabetes may be another mechanism of vascular disease induction. Reduction of EPCs in diabetes is attributable at least in part to the impairment of bone marrow mobilization, which is regulated by the chemokine SDF-1alpha, among others.

The oral hypoglycemia agent sitagliptin is a dipeptidyl dipeptidase-IV inhibitor, which prevents degradation of endogenous incretins (GIP and GLP-1), thus re-equilibrating insulin and glucagon secretion. Sitagliptin may also increase the concentrations of SDF-1alpha, which is another substrate of DPP-IV. The hypothesis is that sitagliptin may increase circulating EPC levels, through SDF-alpha.

This is going to be a pilot, non-randomized controlled 4-week trial of 100 mg oral sitagliptin therapy added to metformin/sulphonylureas in poorly controlled type 2 diabetic patients. At baseline and 4 weeks after the initiation of therapy blood samples will be drawn for the determination of circulating EPC levels, and concentrations of SDF-1alpha. EPCs will be defined as CD34+KDR+ cells and measured by flow cytometry as previously described in detail. SDF-1alpha will be measured using ELISA kits according to the manufacturer's instructions.

Changes between baseline and 4 weeks will be evaluated using two-tailed paired Student's t test and statistical significance accepted at p<0.05.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of 4-week Sitagliptin Therapy on Endothelial Progenitor Cells in Type 2 Diabetic Patients. A Non-randomized Controlled Open-label Pilot Trial.
Study Start Date : October 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment
Sitagliptin 100 mg once daily for 4 weeks
Drug: Sitagliptin
100 mg once daily for 4 weeks
Other Name: Januvia; Xelevia; Tesavel

No Intervention: Control
No change in anti-diabetic treatment regimen for at least 4 weeks.

Primary Outcome Measures :
  1. Change in circulating CD34+KDR+ endothelial progenitor cells [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Change in SDF-1alpha concentrations [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 2 diabetes;
  • Both genders
  • Age 40-80
  • fasting c-peptide >=1.0 ng/L
  • Therapy with metformin or sulphonylureas
  • HbA1c >7.0%
  • No contraindications to sitagliptin use

Exclusion Criteria:

  • Type 1 diabetes
  • Age <40 or >80
  • fasting c-peptide <1.0 ng/L
  • Therapy with TZD
  • HbA1c <=7.0%
  • Acute concomitant diseases
  • Immunological disorders
  • Recent (within 3 months) cardiovascular events or surgery
  • Pregnancy and lactation
  • Inability to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00968006

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University of Padova, Medical School
Padova, Italy, 35100
Sponsors and Collaborators
University of Padova
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Principal Investigator: Angelo Avogaro, MD PhD Dept. Clinical and Experimental Medicine, University of Padova, Medical School, Padova (Italy)

Publications of Results:
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Responsible Party: Angelo Avogaro, Associate Professor (PI), Dept Clinical and Experimental Medicine, University of Padova Medical School Identifier: NCT00968006    
Other Study ID Numbers: Sita-EPC
First Posted: August 28, 2009    Key Record Dates
Last Update Posted: April 5, 2010
Last Verified: April 2010
Keywords provided by University of Padova:
stem cells
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action