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Article ; Online: A muscarinic receptor antagonist reverses multiple indices of diabetic peripheral neuropathy: preclinical and clinical studies using oxybutynin.

Casselini, Carolina M / Parson, Henri K / Frizzi, Katie E / Marquez, Alex / Smith, Darrell R / Guernsey, Lucie / Nemmani, Rakesh / Tayarani, Alireza / Jolivalt, Corinne G / Weaver, Jessica / Fernyhough, Paul / Vinik, Aaron I / Calcutt, Nigel A

Acta neuropathologica

2024 Volume 147, Issue 1, Page(s) 60

Abstract: Preclinical studies indicate that diverse muscarinic receptor antagonists, acting via the ... ...

Abstract	Preclinical studies indicate that diverse muscarinic receptor antagonists, acting via the M
MeSH term(s)	Animals ; Humans ; Mice ; Rats ; Diabetes Mellitus, Experimental/complications ; Diabetes Mellitus, Experimental/drug therapy ; Diabetes Mellitus, Experimental/pathology ; Diabetes Mellitus, Type 2/complications ; Diabetes Mellitus, Type 2/drug therapy ; Diabetic Neuropathies/drug therapy ; Diabetic Neuropathies/complications ; Diabetic Neuropathies/pathology ; Mandelic Acids ; Muscarinic Antagonists/pharmacology ; Muscarinic Antagonists/therapeutic use ; Quality of Life ; Receptors, Muscarinic ; Diabetes Mellitus, Type 1
Chemical Substances	Mandelic Acids ; Muscarinic Antagonists ; oxybutynin (K9P6MC7092) ; Receptors, Muscarinic
Language	English
Publishing date	2024-03-25
Publishing country	Germany
Document type	Randomized Controlled Trial ; Journal Article
ZDB-ID	1079-0
ISSN	1432-0533 ; 0001-6322
ISSN (online)	1432-0533
ISSN	0001-6322
DOI	10.1007/s00401-024-02710-4
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Article ; Online: Programming a Ferroptosis-to-Apoptosis Transition Landscape Revealed Ferroptosis Biomarkers and Repressors for Cancer Therapy.

Vinik, Yaron / Maimon, Avi / Dubey, Vinay / Raj, Harsha / Abramovitch, Ifat / Malitsky, Sergey / Itkin, Maxim / Ma'ayan, Avi / Westermann, Frank / Gottlieb, Eyal / Ruppin, Eytan / Lev, Sima

Advanced science (Weinheim, Baden-Wurttemberg, Germany)

2024 , Page(s) e2307263

Abstract: Ferroptosis and apoptosis are key cell-death pathways implicated in several human diseases including cancer. Ferroptosis is driven by iron-dependent lipid peroxidation and currently has no characteristic biomarkers or gene signatures. Here a continuous ... ...

Abstract	Ferroptosis and apoptosis are key cell-death pathways implicated in several human diseases including cancer. Ferroptosis is driven by iron-dependent lipid peroxidation and currently has no characteristic biomarkers or gene signatures. Here a continuous phenotypic gradient between ferroptosis and apoptosis coupled to transcriptomic and metabolomic landscapes is established. The gradual ferroptosis-to-apoptosis transcriptomic landscape is used to generate a unique, unbiased transcriptomic predictor, the Gradient Gene Set (GGS), which classified ferroptosis and apoptosis with high accuracy. Further GGS optimization using multiple ferroptotic and apoptotic datasets revealed highly specific ferroptosis biomarkers, which are robustly validated in vitro and in vivo. A subset of the GGS is associated with poor prognosis in breast cancer patients and PDXs and contains different ferroptosis repressors. Depletion of one representative, PDGFA-assaociated protein 1(PDAP1), is found to suppress basal-like breast tumor growth in a mouse model. Omics and mechanistic studies revealed that ferroptosis is associated with enhanced lysosomal function, glutaminolysis, and the tricarboxylic acid (TCA) cycle, while its transition into apoptosis is attributed to enhanced endoplasmic reticulum(ER)-stress and phosphatidylethanolamine (PE)-to-phosphatidylcholine (PC) metabolic shift. Collectively, this study highlights molecular mechanisms underlying ferroptosis execution, identified a highly predictive ferroptosis gene signature with prognostic value, ferroptosis versus apoptosis biomarkers, and ferroptosis repressors for breast cancer therapy.
Language	English
Publishing date	2024-03-05
Publishing country	Germany
Document type	Journal Article
ZDB-ID	2808093-2
ISSN	2198-3844 ; 2198-3844
ISSN (online)	2198-3844
ISSN	2198-3844
DOI	10.1002/advs.202307263
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Article ; Online: The efficacy of pregabalin for treating pain associated with diabetic peripheral neuropathy in subjects with type 1 or type 2 diabetes mellitus.

Parsons, B / Li, C / Emir, B / Vinik, A I

Current medical research and opinion

2018 Volume 34, Issue 11, Page(s) 2015–2022

Abstract: Objective: The objective of this study was to compare the efficacy and safety of pregabalin for painful diabetic peripheral neuropathy (pDPN) in subjects with type 1 (T1DM) or 2 diabetes mellitus (T2DM).: Methods: Pooled data from 10 randomized ... ...

Abstract	Objective: The objective of this study was to compare the efficacy and safety of pregabalin for painful diabetic peripheral neuropathy (pDPN) in subjects with type 1 (T1DM) or 2 diabetes mellitus (T2DM). Methods: Pooled data from 10 randomized clinical trials (pregabalin-treated T1DM and T2DM subjects with pDPN) were analyzed for change from baseline (CFB) scores (pain and sleep disturbance) using mixed model repeated measures (MMRM) through Week 12 and last observation carried forward (LOCF). Adverse events (AEs) were recorded. Results: Pregabalin-treated (T1DM 156 [8.7%]; T2DM 1632 [91.3%]) and placebo subjects (T1DM 92 [9.6%]; T2DM 868 [90.4%]) had comparable baseline demographic characteristics between treatment groups within the same diabetes type. T2DM (vs. T1DM) subjects were ∼10 years older. With pregabalin and placebo, respectively, mean ± SD baseline pain (T1DM: 6.2 ± 1.4 and 6.5 ± 1.6; T2DM: 6.5 ± 1.5 and 6.4 ± 1.5) and sleep scores (T1DM: 5.2 ± 2.4 and 5.2 ± 2.7; T2DM: 5.3 ± 2.5 and 5.1 ± 2.5) were comparable. Using MMRM, mean CFB treatment differences (pregabalin minus placebo) were significantly different for pain and sleep with either diabetes types (all weeks p < .05). With LOCF, pregabalin's odds ratios (ORs) of achieving 30% pain reduction were similar with T2DM (OR, 1.91, 95% CI [1.61, 2.27]) and T1DM (2.01 [1.18, 3.44]) (both p ≤ .01). Pregabalin's ORs of 30% improvement in sleep quality were 1.81 (95% CI, 1.06, 3.09) with T1DM and 2.01 (1.69, 2.39) with T2DM (both p < .05). AEs were consistent with the known safety profile of pregabalin. Conclusions: Pregabalin significantly improved pain and sleep quality, without a clinically meaningful difference between diabetes types. ClinicalTrial.gov registration: NCT00156078, NCT00159679, NCT00143156, NCT00553475.
MeSH term(s)	Analgesics/administration & dosage ; Analgesics/adverse effects ; Diabetes Mellitus, Type 1/complications ; Diabetes Mellitus, Type 2/complications ; Diabetic Neuropathies/diagnosis ; Diabetic Neuropathies/drug therapy ; Diabetic Neuropathies/etiology ; Double-Blind Method ; Drug Monitoring/methods ; Dyssomnias/diagnosis ; Dyssomnias/drug therapy ; Dyssomnias/etiology ; Female ; Humans ; Male ; Middle Aged ; Pain Measurement/methods ; Pregabalin/administration & dosage ; Pregabalin/adverse effects ; Randomized Controlled Trials as Topic ; Treatment Outcome
Chemical Substances	Analgesics ; Pregabalin (55JG375S6M)
Language	English
Publishing date	2018-09-20
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	80296-7
ISSN	1473-4877 ; 0300-7995
ISSN (online)	1473-4877
ISSN	0300-7995
DOI	10.1080/03007995.2018.1509304
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Article ; Online: Alternative Quantitative Tools in the Assessment of Diabetic Peripheral and Autonomic Neuropathy.

Vinik, A I / Casellini, C / Névoret, M-L

International review of neurobiology

2016 Volume 127, Page(s) 235–285

Abstract: Here we review some seldom-discussed presentations of diabetic neuropathy, including large fiber dysfunction and peripheral autonomic dysfunction, emphasizing the impact of sympathetic/parasympathetic imbalance. Diabetic neuropathy is the most common ... ...

Abstract	Here we review some seldom-discussed presentations of diabetic neuropathy, including large fiber dysfunction and peripheral autonomic dysfunction, emphasizing the impact of sympathetic/parasympathetic imbalance. Diabetic neuropathy is the most common complication of diabetes and contributes additional risks in the aging adult. Loss of sensory perception, loss of muscle strength, and ataxia or incoordination lead to a risk of falling that is 17-fold greater in the older diabetic compared to their young nondiabetic counterparts. A fall is accompanied by lacerations, tears, fractures, and worst of all, traumatic brain injury, from which more than 60% do not recover. Autonomic neuropathy has been hailed as the "Prophet of Doom" for good reason. It is conducive to increased risk of myocardial infarction and sudden death. An imbalance in the autonomic nervous system occurs early in the evolution of diabetes, at a stage when active intervention can abrogate the otherwise relentless progression. In addition to hypotension, many newly recognized syndromes can be attributed to cardiac autonomic neuropathy such as orthostatic tachycardia and bradycardia. Ultimately, this constellation of features of neuropathy conspire to impede activities of daily living, especially in the patient with pain, anxiety, depression, and sleep disorders. The resulting reduction in quality of life may worsen prognosis and should be routinely evaluated and addressed. Early neuropathy detection can only be achieved by assessment of both large and small- nerve fibers. New noninvasive sudomotor function technologies may play an increasing role in identifying early peripheral and autonomic neuropathy, allowing rapid intervention and potentially reversal of small-fiber loss.
MeSH term(s)	Aging ; Animals ; Autonomic Nervous System Diseases/diagnosis ; Autonomic Nervous System Diseases/etiology ; Autonomic Nervous System Diseases/psychology ; Diabetic Neuropathies/complications ; Diabetic Neuropathies/diagnosis ; Diabetic Neuropathies/psychology ; Humans ; Quality of Life/psychology
Language	English
Publishing date	2016
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	209876-3
ISSN	2162-5514 ; 0074-7742
ISSN (online)	2162-5514
ISSN	0074-7742
DOI	10.1016/bs.irn.2016.03.010
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Article: Countering the Modern Metabolic Disease Rampage With Ancestral Endocannabinoid System Alignment.

Pepper, Ian / Vinik, Aaron / Lattanzio, Frank / McPheat, William / Dobrian, Anca

Frontiers in endocrinology

2019 Volume 10, Page(s) 311

Abstract: When primitive vertebrates evolved from ancestral members of the animal kingdom and acquired complex locomotive and neurological toolsets, a constant supply of energy became necessary for their continued survival. To help fulfill this need, the ... ...

Abstract	When primitive vertebrates evolved from ancestral members of the animal kingdom and acquired complex locomotive and neurological toolsets, a constant supply of energy became necessary for their continued survival. To help fulfill this need, the endocannabinoid (eCB) system transformed drastically with the addition of the cannabinoid-1 receptor (CB1R) to its gene repertoire. This established an eCB/CB1R signaling mechanism responsible for governing the whole organism's energy balance, with its activation triggering a shift toward energy intake and storage in the brain and the peripheral organs (i.e., liver and adipose). Although this function was of primal importance for humans during their pre-historic existence as hunter-gatherers, it became expendable following the successive lifestyle shifts of the Agricultural and Industrial Revolutions. Modernization of the world has further increased food availability and decreased energy expenditure, thus shifting the eCB/CB1R system into a state of hyperactive deregulated signaling that contributes to the 21st century metabolic disease pandemic. Studies from the literature supporting this perspective come from a variety of disciplines, including biochemistry, human medicine, evolutionary/comparative biology, anthropology, and developmental biology. Consideration of both biological and cultural evolution justifies the design of improved pharmacological treatments for obesity and Type 2 diabetes (T2D) that focus on peripheral CB1R antagonism. Blockade of peripheral CB1Rs, which universally promote energy conservation across the vertebrate lineage, represents an evolutionary medicine strategy for clinical management of present-day metabolic disorders.
Language	English
Publishing date	2019-05-17
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2592084-4
ISSN	1664-2392
ISSN	1664-2392
DOI	10.3389/fendo.2019.00311
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Article ; Online: Case-Control Study of Paresthesia Among World Trade Center-Exposed Community Members.

Marmor, Michael / Thawani, Sujata / Cotrina, Maria Luisa / Shao, Yongzhao / Wong, Ericka S / Stecker, Mark M / Wang, Bin / Allen, Alexander / Wilkenfeld, Marc / Vinik, Etta J / Vinik, Aaron I / Reibman, Joan

Journal of occupational and environmental medicine

2020 Volume 62, Issue 4, Page(s) 307–316

Abstract: Objective: To investigate whether paresthesia of the lower extremities following exposure to the World Trade Center (WTC) disaster was associated with signs of neuropathy, metabolic abnormalities, or neurotoxin exposures.: Methods: Case-control study ...

Abstract	Objective: To investigate whether paresthesia of the lower extremities following exposure to the World Trade Center (WTC) disaster was associated with signs of neuropathy, metabolic abnormalities, or neurotoxin exposures. Methods: Case-control study comparing WTC-exposed paresthesia cases with "clinic controls" (WTC-exposed subjects without paresthesias), and "community controls" (WTC-unexposed persons). Results: Neurological histories and examination findings were significantly worse in cases than controls. Intraepidermal nerve fiber densities were below normal in 47% of cases and sural to radial sensory nerve amplitude ratios were less than 0.4 in 29.4%. Neurologic abnormalities were uncommon among WTC-unexposed community controls. Metabolic conditions and neurotoxin exposures did not differ among groups. Conclusions: Paresthesias among WTC-exposed individuals were associated with signs of neuropathy, small and large fiber disease. The data support WTC-related exposures as risk factors for neuropathy, and do not support non-WTC etiologies.
MeSH term(s)	Adult ; Case-Control Studies ; Disasters ; Dust ; Female ; Humans ; Male ; Middle Aged ; New York City/epidemiology ; Occupational Exposure/statistics & numerical data ; Paresthesia/epidemiology ; Risk Factors ; September 11 Terrorist Attacks
Chemical Substances	Dust
Language	English
Publishing date	2020-02-11
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	1223932-x
ISSN	1536-5948 ; 1076-2752
ISSN (online)	1536-5948
ISSN	1076-2752
DOI	10.1097/JOM.0000000000001828
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Article ; Online: Epidemiology of Diabetic Foot Ulcers and Amputations in Romania: Results of a Cross-Sectional Quality of Life Questionnaire Based Survey.

Bondor, Cosmina I / Veresiu, Ioan A / Florea, Bogdan / Vinik, Etta J / Vinik, Aaron I / Gavan, Norina A

Journal of diabetes research

2016 Volume 2016, Page(s) 5439521

Abstract: This is a post hoc analysis of quality of life in diabetic neuropathy patients in a cross-sectional survey performed in 2012 in Romania, using the Norfolk QOL-DN in which 21,756 patients with self-reported diabetes were enrolled. This current analysis ... ...

Abstract	This is a post hoc analysis of quality of life in diabetic neuropathy patients in a cross-sectional survey performed in 2012 in Romania, using the Norfolk QOL-DN in which 21,756 patients with self-reported diabetes were enrolled. This current analysis aims to expand research on the diabetic foot and to provide an update on the number of foot ulcers found in Romania. Of the 21,174 patients included in this analysis, 14.85% reported a history of foot ulcers and 3.60% reported an amputation. The percentage of neuropathy patients with foot ulcers increased with age; the lowest percentage was observed in the 20-29-year age group (6.62%) and the highest in the 80-89-year age group (17.68%). The highest number of amputations was reported in the 70-79-year age group (largest group). Compared to patients without foot ulcers, those with foot ulcers had significantly higher scores for total DN and all its subdomains translating to worse QOL (p < 0.001). This analysis showed a high rate of foot ulcers and amputations in Romanian diabetic patients. It underscores the need for implementation of effective screening and educational programs.
MeSH term(s)	Adult ; Age Distribution ; Aged ; Aged, 80 and over ; Amputation ; Cross-Sectional Studies ; Diabetic Foot/diagnosis ; Diabetic Foot/epidemiology ; Diabetic Foot/psychology ; Diabetic Foot/surgery ; Female ; Health Care Surveys ; Humans ; Male ; Middle Aged ; Prevalence ; Quality of Life ; Romania/epidemiology ; Surveys and Questionnaires ; Treatment Outcome ; Young Adult
Language	English
Publishing date	2016-02-25
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2711897-6
ISSN	2314-6753 ; 2314-6745
ISSN (online)	2314-6753
ISSN	2314-6745
DOI	10.1155/2016/5439521
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Article ; Online: Delay between Onset of Symptoms and Seeking Physician Intervention Increases Risk of Diabetic Foot Complications: Results of a Cross-Sectional Population-Based Survey.

Gavan, Norina A / Veresiu, Ioan A / Vinik, Etta J / Vinik, Aaron I / Florea, Bogdan / Bondor, Cosmina I

Journal of diabetes research

2016 Volume 2016, Page(s) 1567405

Abstract: We present a post hoc analysis of 17,530 questionnaires collected as part of the 2012 screening for neuropathy using Norfolk Quality of Life tool in patients with diabetes in Romania, to assess the impact on foot complications of time between the onset ... ...

Abstract	We present a post hoc analysis of 17,530 questionnaires collected as part of the 2012 screening for neuropathy using Norfolk Quality of Life tool in patients with diabetes in Romania, to assess the impact on foot complications of time between the onset of symptoms of diabetes/its complications and the physician visit. Odds ratios (ORs) for self-reporting neuropathy increased from 1.16 (95% CI: 1.07-1.25) in those who sought medical care in 1-6 months from symptoms of diabetes/its complications onset to 2.27 in those who sought medical care >2 years after symptoms onset. The ORs for having a history of foot ulcers were 1.43 (95% CI: 1.26-1.63) in those who sought medical care in 1-6 months and increased to 3.08 (95% CI: 2.59-3.66) in those who sought medical care after >2 years from symptoms of diabetes/its complications onset. The highest ORs for a history of gangrene (2.49 [95% CI: 1.90-3.26]) and amputations (2.18 [95% CI: 1.60-2.97]) were observed in those who sought medical care after >2 years following symptoms onset. In conclusion, we showed that waiting for >1 month after symptoms onset dramatically increases the risk of diabetic foot complications. These results show the need for accessible educational programs on diabetes and its chronic complications and the need to avoid delays in reporting.
MeSH term(s)	Aged ; Amputation ; Cross-Sectional Studies ; Delayed Diagnosis ; Diabetic Foot/complications ; Diabetic Foot/diagnosis ; Diabetic Foot/therapy ; Diabetic Neuropathies/diagnosis ; Diabetic Neuropathies/therapy ; Female ; Gangrene/complications ; Humans ; Male ; Middle Aged ; Odds Ratio ; Probability ; Quality of Life ; Risk ; Romania ; Surveys and Questionnaires ; Time Factors ; Waiting Lists
Language	English
Publishing date	2016-11-29
Publishing country	England
Document type	Journal Article
ZDB-ID	2711897-6
ISSN	2314-6753 ; 2314-6745
ISSN (online)	2314-6753
ISSN	2314-6745
DOI	10.1155/2016/1567405
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Article ; Online: Development and Validation of the Norfolk Quality of Life Fatigue Tool (QOL-F): A New Measure of Perception of Fatigue.

Vinik, Etta J / Vinik, Aaron I / Neumann, Serina A / Lamichhane, Rajan / Morrison, Steven / Colberg, Sheri R / Lai, Ying-Chuen / Paulson, James / Handel, Richard / Casellini, Carolina / Hodges, Kim / Edwards, Joshua / Parson, Henri K

Journal of the American Medical Directors Association

2019 Volume 21, Issue 9, Page(s) 1267–1272.e2

Abstract: Objectives: To design a questionnaire to evaluate and distinguish between cognitive and physical aspects of fatigue in different age groups of "nondiseased" people and guide appropriate prevention and interventions for the impact of frailty occurring in ...

Abstract	Objectives: To design a questionnaire to evaluate and distinguish between cognitive and physical aspects of fatigue in different age groups of "nondiseased" people and guide appropriate prevention and interventions for the impact of frailty occurring in normative aging. Study design and participants: The Norfolk QOL-Fatigue (QOL-F) with items of cognitive and physical fatigue, anxiety, and depression from validated questionnaires including items from the Patient-Reported Outcomes Measure Information System (PROMIS) databank was developed. The preliminary QOL-F was administered to 409 healthy multiethnic local participants (30-80 years old) in 5 age groups. Methods: The authors distilled the item pool using exploratory (EFA) and confirmatory factor analysis (CFA). EFA identified 5 latent groups as possible factors related to problems due to fatigue, subjective fatigue, reduced activities, impaired activities of daily living (ADL), and depression. Results: CFA demonstrated good overall fit [χ Conclusions and clinical implications: The developed Norfolk QOL-F tool demonstrated fatigue as a perceived cognitive phenomenon rather than an objective physical measure, suggesting mandatory inclusion of cognitive as well as physical measures in the evaluation of people as they age. QOL-F is able to distinguish QOL-F domain scores unique to different age groups, proposing clinical benefits from physical, balance, and cognitive interventions tailored to impact frailty occurring in normative aging.
MeSH term(s)	Activities of Daily Living ; Adult ; Aged ; Aged, 80 and over ; Fatigue ; Female ; Humans ; Male ; Middle Aged ; Perception ; Psychometrics ; Quality of Life ; Reproducibility of Results ; Surveys and Questionnaires
Language	English
Publishing date	2019-12-16
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2171030-2
ISSN	1538-9375 ; 1525-8610
ISSN (online)	1538-9375
ISSN	1525-8610
DOI	10.1016/j.jamda.2019.10.021
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Article: The Role of Gut Microflora and the Cholinergic Anti-inflammatory Neuroendocrine System in Diabetes Mellitus.

Parekh, Parth J / Nayi, Vipul R / Johnson, David A / Vinik, Aaron I

Frontiers in endocrinology

2016 Volume 7, Page(s) 55

Abstract: The obesity epidemic has drastically impacted the state of health care in the United States. Paralleling this epidemic is the incidence of diabetes mellitus, with a notable shift toward a much younger age of onset. While central to the pathogenesis of ... ...

Abstract	The obesity epidemic has drastically impacted the state of health care in the United States. Paralleling this epidemic is the incidence of diabetes mellitus, with a notable shift toward a much younger age of onset. While central to the pathogenesis of diabetes associated with obesity is the role of inflammation attributed to "adiposopathy." Emerging data suggest that changes in sympathetic/parasympathetic balance regulated by the brain precede changes in the inflammatory cascade. It has now been established that the gut microflora contributes significantly to the activation and inhibition of autonomic control and impact the set of the neuroinflammatory inhibitory reflex mediated by the cholinergic nervous system. There has been a paradigm shift toward further investigating commensal bacteria in the pathogenesis of obesity and diabetes mellitus and its complications, as dysbiosis is thought to play a pivotal role in diabetic-associated disorders. This paper is intended to evaluate the role of intestinal dysbiosis in the pathogenesis of diabetes mellitus and examine the potential for restoration of balance via use of probiotics.
Language	English
Publishing date	2016-06-08
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2592084-4
ISSN	1664-2392
ISSN	1664-2392
DOI	10.3389/fendo.2016.00055
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