Dear Editor
This indeed a very good article on emerging class of antidiabetic drugs i.e SGLT2 inhibitors. SGLT2 inhibitors are making their way not only for their role as an adjuvant therapy for control of diabetes, but their beneficial role in providing cardiac safety, renal protection and weight reduction are making these drugs superior in comparison to DPP4 inhibitors, which are another widely used and well tolerated anti diabetic drugs. SGLT2 inhibitors are known to lower blood glucose by inhibiting glucose and sodium re absorption and promoting glycosuria, as a consequence they cause glucose and HbA1C reduction and lowering of blood pressure1. A part from these benefits , SGLT2 inhibitors might acquire potential indication to be used for prevention and treatment of gout due to their uric acid reducing properties2.
Since these drugs got FDA approval and become available, the side effect profile of these drugs have always remained talk of major debates. Well known side effects are genital infection, increase incidence of mycotic infections and diabetic ketoacidosis. One of the major and serious concern with use of SGLT2 inhibitors is possibility of Fournier’s gangrene. Fournier’s gangrene is an extremely rare but life-threatening bacterial infection of the genital tissue. Current article is also reflection of my own experience. I have been prescribing SGLT2 inhibitors quite frequently and most of the patients are in regular follow up and I have not seen any...
Dear Editor
This indeed a very good article on emerging class of antidiabetic drugs i.e SGLT2 inhibitors. SGLT2 inhibitors are making their way not only for their role as an adjuvant therapy for control of diabetes, but their beneficial role in providing cardiac safety, renal protection and weight reduction are making these drugs superior in comparison to DPP4 inhibitors, which are another widely used and well tolerated anti diabetic drugs. SGLT2 inhibitors are known to lower blood glucose by inhibiting glucose and sodium re absorption and promoting glycosuria, as a consequence they cause glucose and HbA1C reduction and lowering of blood pressure1. A part from these benefits , SGLT2 inhibitors might acquire potential indication to be used for prevention and treatment of gout due to their uric acid reducing properties2.
Since these drugs got FDA approval and become available, the side effect profile of these drugs have always remained talk of major debates. Well known side effects are genital infection, increase incidence of mycotic infections and diabetic ketoacidosis. One of the major and serious concern with use of SGLT2 inhibitors is possibility of Fournier’s gangrene. Fournier’s gangrene is an extremely rare but life-threatening bacterial infection of the genital tissue. Current article is also reflection of my own experience. I have been prescribing SGLT2 inhibitors quite frequently and most of the patients are in regular follow up and I have not seen any patient coming up with necrotizing infection of perineum. Therefore considering the diverse beneficial effects associated with this class of drug, it should be considered wherever required.
References:
Pereira, M.J., Eriksson, J.W. Emerging Role of SGLT-2 Inhibitors for the Treatment of Obesity. Drugs 79, 219–230 (2019) doi:10.1007/s40265-019-1057-0
Bailey, CJ. Uric acid and the cardio‐renal effects of SGLT2 inhibitors. Diabetes Obes Metab. 2019; 21: 1291– 1298. https://doi.org/10.1111/dom.13670
We thank the authors for their question and interest in our article. The two cited articles (1,2) are very interesting but differ from what we wanted to show with the St. Carlos GDM Prevention Study (3). The first one is a case-control study analyzing associations of DASH and Mediterranean diets with GDM (1). The second one evaluates the effect of a nutritional intervention with a Mediterranean diet on postpartum development of glucose disorders in women with prior GDM (2). The St. Carlos GDM Prevention Study was a randomized controlled trial that analyzed the effect a nutritional intervention with a MedDiet, supplemented with extra virgin olive oil and nuts, on GDM development.
The motive women were given extra virgin olive oil was to ensure a high compliance with the MedDiet. Not only women increased their intake in these two foods, but also increased their overall MEDAS score (3). This also seemed to translate in a substitution of unhealthy foods for healthy ones. For example, a substitution of unhealthy snacks for nuts and of processed sauces and dressings for olive oil and olive oil-based sauces. The ultimate message we were hoping to convey is that extra virgin olive oil and nuts should be consumed more, with less restrictions. Current Spanish guidelines advise a controlled consumption of these foods in pregnancy.
The type of medical nutrition therapy used in GDM treatment is not standardized and can be different between centers. Due to the results found...
We thank the authors for their question and interest in our article. The two cited articles (1,2) are very interesting but differ from what we wanted to show with the St. Carlos GDM Prevention Study (3). The first one is a case-control study analyzing associations of DASH and Mediterranean diets with GDM (1). The second one evaluates the effect of a nutritional intervention with a Mediterranean diet on postpartum development of glucose disorders in women with prior GDM (2). The St. Carlos GDM Prevention Study was a randomized controlled trial that analyzed the effect a nutritional intervention with a MedDiet, supplemented with extra virgin olive oil and nuts, on GDM development.
The motive women were given extra virgin olive oil was to ensure a high compliance with the MedDiet. Not only women increased their intake in these two foods, but also increased their overall MEDAS score (3). This also seemed to translate in a substitution of unhealthy foods for healthy ones. For example, a substitution of unhealthy snacks for nuts and of processed sauces and dressings for olive oil and olive oil-based sauces. The ultimate message we were hoping to convey is that extra virgin olive oil and nuts should be consumed more, with less restrictions. Current Spanish guidelines advise a controlled consumption of these foods in pregnancy.
The type of medical nutrition therapy used in GDM treatment is not standardized and can be different between centers. Due to the results found in our study, we think that a MedDiet-based medical nutrition therapy can be appropriate for GDM treatment (4). To improve the adherence to this diet, it is very important to recommend increasing the intake of extra virgin olive oil and nuts.
In view of the foregoing, we do think that it might be worthy considering a modification of both the nutrition and pregnancy guidelines and medical nutrition therapy in GDM treatment.
1. Izadi V, Tehrani H, Haghighatdoost F, et.al. Adherence to the DASH and Mediterranean diets is associated with decreased risk for gestational diabetes mellitus. Nutrition 2016;32:1092-6. doi:10.1016/j.nut.2016.03.006.
2. Perez-Ferre N, Valle LD, Torrej MJ, et.al. Diabetes Mellitus and Abnormal Glucose Tolerance Development After Gestational Diabetes: A Three-year, Prospective, Randomized, Clinical based, Mediterranean lifestyle Interventional Study with Parallel Groups. Clinical Nutrition 2015;34:579-585. doi:10.1016/j.clnu.2014.09.005.
3. Assaf-Balut C, García de la Torre N, Durán, A, et al. A Mediterranean diet with additional extra virgin olive oil and pistachios reduces the incidence of gestational diabetes mellitus (GDM): A randomized controlled trial: The St. Carlos GDM prevention study. PLoS One. 2017;12:e0185873. doi:10.1371/journal.pone.0185873.
4. Assaf-Balut C, García de la Torre N, Durán, A, Medical nutrition therapy for gestational diabetes mellitus based on Mediterranean Diet principles: a subanalysis of the St Carlos GDM Prevention Study. BMJ Open Diabetes Res Care.2018. 11;6:e000550. doi: 10.1136/bmjdrc-2018-000550.
As author of the Diabetes Health Profile, I felt that overall the paper provided a generally balanced report of your study, I have however, a number of issues regarding your report.
First, although resulting in a high alpha coefficient (0.79), it is incorrect to calculate an alpha score for the total number of items when the scale itself is multidimensional (Oranges and apples). In doing so, it can result in an overall low alpha score. In this case it is fortunate that the value was high. Had this been a low score this would have been perceived as a negative result to the less knowledgeable.
Secondly, with regard to responsiveness to change, a crude method for measuring change in score was used together with a very limited patient sample. Although the limitation of the methodology was discussed to some extent in the discussion, it would have been preferable at least to measure at both pre and post for each of the three scale domains. Minimally Important Difference (MID) values are available for the DHP that would enable the smallest change in score that is clinically significant to be measured.
Thirdly, in the section ‘Significance of the study’ it would have been more appropriate that the final comment on implementation in clinical practice and studies should have been limited to the ‘Norwegian’ version of the DHP-18. As currently phrased this is rather general and suggests the use of the DHP-18 in clinical studies per se.
As author of the Diabetes Health Profile, I felt that overall the paper provided a generally balanced report of your study, I have however, a number of issues regarding your report.
First, although resulting in a high alpha coefficient (0.79), it is incorrect to calculate an alpha score for the total number of items when the scale itself is multidimensional (Oranges and apples). In doing so, it can result in an overall low alpha score. In this case it is fortunate that the value was high. Had this been a low score this would have been perceived as a negative result to the less knowledgeable.
Secondly, with regard to responsiveness to change, a crude method for measuring change in score was used together with a very limited patient sample. Although the limitation of the methodology was discussed to some extent in the discussion, it would have been preferable at least to measure at both pre and post for each of the three scale domains. Minimally Important Difference (MID) values are available for the DHP that would enable the smallest change in score that is clinically significant to be measured.
Thirdly, in the section ‘Significance of the study’ it would have been more appropriate that the final comment on implementation in clinical practice and studies should have been limited to the ‘Norwegian’ version of the DHP-18. As currently phrased this is rather general and suggests the use of the DHP-18 in clinical studies per se.
Finally, permission to use the DHP-18 was given by Oxford University Innovation, not Dr David Churchman.
T2DM first problem still open is to recognize diabetics so far without proper diagnosis, in order to avoid the series of complications that arise decades before the clinical diabetic symptomatology decades before the clinical diabetic symptomatologyFDA Commissioner Scott Gottlieb, MD, said: "Diabetes affects nearly 30 million Americans. Access to affordable insulin is literally a matter of life and death". Aurobindo would say this is a true and false statement. Why do we all, including FDA, not radically solve the real problem underlying the diabetic growing epidemic? Let's start talking about Pre-Primary and Primary Prevention of T2DM, based on Diabetic and Dislipidemic-Dependent, Inherited Real Risk, bedside diagnosed from birth with a stethoscope, and removed by inexpensive Reconstructing Mitochodrial Quantum Therapy. The till now open problem in the traditional Accademic Medicine is the clinical diagnosis of T2DM from the First of its Five Stages. Well. Recently, a new and original reliable clinical method for diagnosing DM has been added to a flurry of methods that have existed for twenty years. The Corpus Callosum is the part of the brainthat allows communication between its two hemispheres. It is responsible for transmitting neural messages between both the right and left hemispheres. According to Angiobiopathy Theory, microvessel dynamic parallels the related parenchima cell activity. As a consequence,thanks to Quantum Biophysical Semeiotic, physi...
T2DM first problem still open is to recognize diabetics so far without proper diagnosis, in order to avoid the series of complications that arise decades before the clinical diabetic symptomatology decades before the clinical diabetic symptomatologyFDA Commissioner Scott Gottlieb, MD, said: "Diabetes affects nearly 30 million Americans. Access to affordable insulin is literally a matter of life and death". Aurobindo would say this is a true and false statement. Why do we all, including FDA, not radically solve the real problem underlying the diabetic growing epidemic? Let's start talking about Pre-Primary and Primary Prevention of T2DM, based on Diabetic and Dislipidemic-Dependent, Inherited Real Risk, bedside diagnosed from birth with a stethoscope, and removed by inexpensive Reconstructing Mitochodrial Quantum Therapy. The till now open problem in the traditional Accademic Medicine is the clinical diagnosis of T2DM from the First of its Five Stages. Well. Recently, a new and original reliable clinical method for diagnosing DM has been added to a flurry of methods that have existed for twenty years. The Corpus Callosum is the part of the brainthat allows communication between its two hemispheres. It is responsible for transmitting neural messages between both the right and left hemispheres. According to Angiobiopathy Theory, microvessel dynamic parallels the related parenchima cell activity. As a consequence,thanks to Quantum Biophysical Semeiotic, physicians are able to bedside recognize in both qualitative and quantitative way, Corpus Callosum microcirculatory wall dynamics. Notoriously, Diabetic and Dislipidemic Constitution-Dependent, Inherited Real Risk can be recognized with a stethoscope starting from birth (1, 2). Regardless of blood glucose, this predisposition to T2DM is characterized also by an increased synthesis of GH-RH, and especially high activity nucleus of the vagus nerve. therefore by a significant increase in the Corpus Callosum activity, ascertained at the beside, as illustrated in my article (3). Interestingly, at rest, the normal activity of Corpus Callosum, easily and quickly assessed on vary large scale, e.g., during any medical examination, allows to exclude the presence of T2DM, starting from birth, namely from its Inherited Real Risk.
References if allowed by Medscape.
1) Sergio Stagnaro and Simone Caramel.Inherited Real Risk of Type 2 Diabetes Mellitus: bedside diagnosis, pathophysiology and primary prevention. Front Endocrinol (Lausanne). 2013; 4: 17. Published online 2013 Feb 26. doi:[10.3389/fendo.2013.00017]http://www.frontiersin.org/Review/ReviewForum.aspx [ [MEDLINE]
2) Stagnaro S., West PJ., Hu FB., Manson JE., Willett WC. Diet and Risk of Type 2 Diabetes. N Engl J Med. 2002 Jan 24;346(4):297-298. [MEDLINE]
3)Sergio Stagnaro (2018) La Valutazione della Microcircolazione nel Corpo Calloso recita un Ruolo importante nella Diagnostica Clinica Semeiotico-Biofisico- Quantistica. http://www.sisbq.org/uploads/5/6/8/7/5687930/corpocalloso.pdf
4) Simone Caramel, Marco Marchionni and Sergio Stagnaro. The Glycocalyx Bedside Evaluation Plays A Central Role in Diagnosing Type 2 Diabetes Mellitus and in its Primary Prevention. Treatment Strategies - Diagnosing Diabetes, Cambridge Research Centre, Volume 6 Issue 1, Pg 41-43. http://viewer.zmags.com/publication/0aafcae9#/0aafcae9/1
5) Caramel S., Marchionni M., Stagnaro S. Morinda citrifolia Plays a Central Role in the Primary Prevention of Mitochondrial-dependent Degenerative Disorders. Asian Pac J Cancer Prev. 2015;16(4):1675. http://www.ncbi.nlm.nih.gov/pubmed/25743850[MEDLINE]
Dear Editor
Show MoreThis indeed a very good article on emerging class of antidiabetic drugs i.e SGLT2 inhibitors. SGLT2 inhibitors are making their way not only for their role as an adjuvant therapy for control of diabetes, but their beneficial role in providing cardiac safety, renal protection and weight reduction are making these drugs superior in comparison to DPP4 inhibitors, which are another widely used and well tolerated anti diabetic drugs. SGLT2 inhibitors are known to lower blood glucose by inhibiting glucose and sodium re absorption and promoting glycosuria, as a consequence they cause glucose and HbA1C reduction and lowering of blood pressure1. A part from these benefits , SGLT2 inhibitors might acquire potential indication to be used for prevention and treatment of gout due to their uric acid reducing properties2.
Since these drugs got FDA approval and become available, the side effect profile of these drugs have always remained talk of major debates. Well known side effects are genital infection, increase incidence of mycotic infections and diabetic ketoacidosis. One of the major and serious concern with use of SGLT2 inhibitors is possibility of Fournier’s gangrene. Fournier’s gangrene is an extremely rare but life-threatening bacterial infection of the genital tissue. Current article is also reflection of my own experience. I have been prescribing SGLT2 inhibitors quite frequently and most of the patients are in regular follow up and I have not seen any...
We thank the authors for their question and interest in our article. The two cited articles (1,2) are very interesting but differ from what we wanted to show with the St. Carlos GDM Prevention Study (3). The first one is a case-control study analyzing associations of DASH and Mediterranean diets with GDM (1). The second one evaluates the effect of a nutritional intervention with a Mediterranean diet on postpartum development of glucose disorders in women with prior GDM (2). The St. Carlos GDM Prevention Study was a randomized controlled trial that analyzed the effect a nutritional intervention with a MedDiet, supplemented with extra virgin olive oil and nuts, on GDM development.
Show MoreThe motive women were given extra virgin olive oil was to ensure a high compliance with the MedDiet. Not only women increased their intake in these two foods, but also increased their overall MEDAS score (3). This also seemed to translate in a substitution of unhealthy foods for healthy ones. For example, a substitution of unhealthy snacks for nuts and of processed sauces and dressings for olive oil and olive oil-based sauces. The ultimate message we were hoping to convey is that extra virgin olive oil and nuts should be consumed more, with less restrictions. Current Spanish guidelines advise a controlled consumption of these foods in pregnancy.
The type of medical nutrition therapy used in GDM treatment is not standardized and can be different between centers. Due to the results found...
As author of the Diabetes Health Profile, I felt that overall the paper provided a generally balanced report of your study, I have however, a number of issues regarding your report.
First, although resulting in a high alpha coefficient (0.79), it is incorrect to calculate an alpha score for the total number of items when the scale itself is multidimensional (Oranges and apples). In doing so, it can result in an overall low alpha score. In this case it is fortunate that the value was high. Had this been a low score this would have been perceived as a negative result to the less knowledgeable.
Secondly, with regard to responsiveness to change, a crude method for measuring change in score was used together with a very limited patient sample. Although the limitation of the methodology was discussed to some extent in the discussion, it would have been preferable at least to measure at both pre and post for each of the three scale domains. Minimally Important Difference (MID) values are available for the DHP that would enable the smallest change in score that is clinically significant to be measured.
Thirdly, in the section ‘Significance of the study’ it would have been more appropriate that the final comment on implementation in clinical practice and studies should have been limited to the ‘Norwegian’ version of the DHP-18. As currently phrased this is rather general and suggests the use of the DHP-18 in clinical studies per se.
Finally, permi...
Show MoreT2DM first problem still open is to recognize diabetics so far without proper diagnosis, in order to avoid the series of complications that arise decades before the clinical diabetic symptomatology decades before the clinical diabetic symptomatologyFDA Commissioner Scott Gottlieb, MD, said: "Diabetes affects nearly 30 million Americans. Access to affordable insulin is literally a matter of life and death". Aurobindo would say this is a true and false statement. Why do we all, including FDA, not radically solve the real problem underlying the diabetic growing epidemic? Let's start talking about Pre-Primary and Primary Prevention of T2DM, based on Diabetic and Dislipidemic-Dependent, Inherited Real Risk, bedside diagnosed from birth with a stethoscope, and removed by inexpensive Reconstructing Mitochodrial Quantum Therapy. The till now open problem in the traditional Accademic Medicine is the clinical diagnosis of T2DM from the First of its Five Stages. Well. Recently, a new and original reliable clinical method for diagnosing DM has been added to a flurry of methods that have existed for twenty years. The Corpus Callosum is the part of the brainthat allows communication between its two hemispheres. It is responsible for transmitting neural messages between both the right and left hemispheres. According to Angiobiopathy Theory, microvessel dynamic parallels the related parenchima cell activity. As a consequence,thanks to Quantum Biophysical Semeiotic, physi...
Show More