Italian researchers focus on macroangiopathy, diabetes, and insulin treatmentsType 2 diabetics interested in knowing more about new research on intensifying oral medication treatment may be interested in an emerging study. The study focused on "add-on" insulin therapy with the drugs detemir ("Levemir" brand) and glargine ("Lantus" brand) in aging patients already diagnosed with certain types of vascular disease.
Italian medical researchers in Milan and Padova recently collaborated to study the effects of "optimized glycaemic control" and insulin therapy for Type 2 diabetics with a concurrent diagnosis of macroangiopathy. Their report will be published in the August issue of "Diabetes, Obesity, and Metabolism."
Do You Know Your EPCs from your CECs?
Fadini et al's article provides an excellent overview of several markers used by doctors. These markers reportedly help identify and gauge the severity of the vascular war that may be going on in the human body. More specifically, a war that can be focused within the lining of some diabetics' vascular (circulatory) systems. Researchers want to confirm ways to identify, quantify, predict, and treat these conditions. They turn to certain markers they may find in the blood or body fluids to help them in their quest.
For example, the interior lining, also called the endothelium, of the vascular system has been reported in earlier research to contain endothelial progenitor cells (EPCs). By definition, EPCs are cells believed to be born in the bone marrow and go forth to help repair damaged blood vessel linings. Based on their article,it appears that having a respectable quantity of EPCs may be a good thing. The Italian researchers here advise that the level of EPCs can be measured and used as a medical clue they called "endothelial regeneration."
Another marker studied, the circulating endothelial cells (CECs), are described in medical literature akin to the corpses of endothelial cells that have been shed from the linings and may be a telltale sign of lining casualties. Readers may gather from the Italian research that the miracles that CECs are credited with performing by patching sites of vascular injury are great; however, elevated CECs are not necessarily a good thing if there is concern about why they are present in elevated amounts. They reference CEC measurement in their study as "endothelial damage."
Fadini et al also looked at a third measurement, the "endothelial activation" based on levels of specific proteins or glycoproteins.
Study Highlights
The Italian research team carefully selected outpatient participants for their study taking care to reject those with other diseases that might confuse the results, e.g., cancer, advanced liver disease, and Type 1 diabetes. Patients using certain medications were also excluded including those taking glitazones and DPP-4 inhibitors. They also report their study was registered on ClinicalTrials.gov and that they subscribed to ethical standards and protocols.
They said their selection criteria targeted:
Italian medical researchers in Milan and Padova recently collaborated to study the effects of "optimized glycaemic control" and insulin therapy for Type 2 diabetics with a concurrent diagnosis of macroangiopathy. Their report will be published in the August issue of "Diabetes, Obesity, and Metabolism."
Do You Know Your EPCs from your CECs?
Fadini et al's article provides an excellent overview of several markers used by doctors. These markers reportedly help identify and gauge the severity of the vascular war that may be going on in the human body. More specifically, a war that can be focused within the lining of some diabetics' vascular (circulatory) systems. Researchers want to confirm ways to identify, quantify, predict, and treat these conditions. They turn to certain markers they may find in the blood or body fluids to help them in their quest.
For example, the interior lining, also called the endothelium, of the vascular system has been reported in earlier research to contain endothelial progenitor cells (EPCs). By definition, EPCs are cells believed to be born in the bone marrow and go forth to help repair damaged blood vessel linings. Based on their article,it appears that having a respectable quantity of EPCs may be a good thing. The Italian researchers here advise that the level of EPCs can be measured and used as a medical clue they called "endothelial regeneration."
Another marker studied, the circulating endothelial cells (CECs), are described in medical literature akin to the corpses of endothelial cells that have been shed from the linings and may be a telltale sign of lining casualties. Readers may gather from the Italian research that the miracles that CECs are credited with performing by patching sites of vascular injury are great; however, elevated CECs are not necessarily a good thing if there is concern about why they are present in elevated amounts. They reference CEC measurement in their study as "endothelial damage."
Fadini et al also looked at a third measurement, the "endothelial activation" based on levels of specific proteins or glycoproteins.
Study Highlights
The Italian research team carefully selected outpatient participants for their study taking care to reject those with other diseases that might confuse the results, e.g., cancer, advanced liver disease, and Type 1 diabetes. Patients using certain medications were also excluded including those taking glitazones and DPP-4 inhibitors. They also report their study was registered on ClinicalTrials.gov and that they subscribed to ethical standards and protocols.
They said their selection criteria targeted:
- Type 2 diabetics;
- HbA1c reading greater than 7.0%;
- On oral agents (medications);
- Age 40-80; and
- "Presence of macroangiopathy (either coronary, peripheral or cerebrovascular artery disease."
Fadini et al describe their test design in detail which reportedly took a patient through a course of adding one of the insulin drugs to their current treatment and then switching to the other drug to track, compare, and contrast those results. Numerous physical and blood tests on 42 patients were recorded as Fadini et al conducted the six month study. Their article details the administration of specific insulin amounts and their methodology of follow-up and testing.
They also mentioned a reminder of the "ACCORD trial" which was "prematurely terminated" while studying insulin therapy when there was a rise in reported deaths of that study's Type 2 diabetics, about 62 years of age. The average age of Fadini et al's participants was about 65 years, and their averages weights were higher than normal.
The Italian team advised of some complications that emerged during their study:
They also mentioned a reminder of the "ACCORD trial" which was "prematurely terminated" while studying insulin therapy when there was a rise in reported deaths of that study's Type 2 diabetics, about 62 years of age. The average age of Fadini et al's participants was about 65 years, and their averages weights were higher than normal.
The Italian team advised of some complications that emerged during their study:
- Three patients "experienced an episode of severe hypoglycaemia" involving both drugs (two with glargine, one with detemir);
- Forty-three mild hypoglycaemic episodes;
- Overall hypoglycaemic episodes with glargine "was more than twofold higher" than with detemir as reported.
The Results
Getting down to the vascular aspects of the results. According to Fadini et al:
Getting down to the vascular aspects of the results. According to Fadini et al:
- They had no differences to report between determir and glargine "in their ability to improve epithelial damage and regeneration;"
- There was some weight gain noted in the use of glargine which may raise other concerns for macroangiopathic patients;
- Endothelial damage tracked by CECs was "rapidly" reduced with glucose control improvements;
- "Restoration of endothelial repair [tracked by EPCs] required a longer period of normalcy" in glucose levels (euglycaemia) and as they speculate, may be related to bone marrow response to the treatment.
The Fadini team closed their report with suggesting that their study may offer insight for patients where "vascular protection" is deemed more pressing than any risks associated with "tight glycaemic control."
A special thanks to Dr. Gian Paolo Fadini, Department of Clinical and Experimental Medicine, Division of Metabolic Diseases, University Hospital of Padova (Italy) for providing extra insight on their research to support this review.
See also my review article on diabetes treatment intensification.
See also my review article on diabetes treatment intensification.
Disclaimer: This is an editorial review only, written by a non-medical author, and subject to change or update. The information and links contained in this article are for educational purposes only to support further inquiry and should not be used for diagnosis or to guide treatment. Any reader who is concerned about his or her health should contact a licensed medical doctor for advice. While every effort is made to ensure accuracy, readers should always refer to the original cited sources for verification and/or any interpretation of source material. Author assumes no liability for content, errors, and/or omissions.
Sources
Sources
- Blann, A.D. et al. (2005, February). Circulating endothelial cells: biomarker of vascular disease. Journal of Thrombosis & Haemostasis. Volume 93(2), 228-35. Retrieved July 25, 2011, from National Center for Biotechnology Information, PubMed, online database.
- Fadini, G. P. et al. (2011, August). Optimized glycaemic control achieved with add-on basal insulin therapy improves indexes of endothelial damage and regeneration in type 2 diabetic patients with macroangiopathy: a randomized crossover trial comparing detemir versus glargine. Diabetes, Obesity & Metabolism, 13(8), 718-725. Retrieved July 23, 2011, from EBSCOhost online database. DOI:10.1111/j.1463-1326.2011.01396.x.
- Gerstein et al. (2008). Effects of intensive glucose lowering in type 2 diabetics [Abstract]. New England Journal of Medicine, Volume 358: 2545-2559. Retrieved July 25, 2011, from organization website.
- Kendall, D.M. (2011). Thiazolidinediones: the case for early use. American Diabetes Association. Retrieved July 25, 2011, from organization website.
- MedicineNet, Inc. (2011, April 27). Definition of Macroangiopathy. Retrieved July 25, 2011, from corporate website.
- MedicineNet, Inc. (2003, February 20). Definition of Endothelial Progenitor Cells. Retrieved July 25, 2011, from corporate website.
- Merriam-Webster, Inc. (2011). Euglycemia. Retrieved July 25, 2011, from online dictionary.
- St. Edwards University. Glycoproteins. Retrieved July 25, 2011, from education website.
- U.S. National Library of Medicine. (2009, February 1). Insulin Detemir (rDNA Origin) Injection. Retrieved July 25, 2011, from Medline Plus online database.
- U.S. National Library of Medicine. (2009, February 1). Insulin Glargine (rDNA Origin) Injection. Retrieved July 25, 2011, from Medline Plus online database.
Article Copyright 2011 by Melanie Hundley, U.S.A. All Rights Reserved. No claim is made to other copyright materials cited.
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