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Active Projects

The role of irisin and other cytokines in ovarian physiology

Principal Investigator: Leonid Poretsky, MD
Sub-Investigators: Tomer Singer, MD; Dimitar Avtanski, Ph.D.

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Sponsor: Katz Institute for Women’s Health Innovation Grants Program
Status: Grant award received; IRB application approved; IA received
IRB#: 20-0499
Description: The purpose of this project is to explore how chronic inflammation modulates the success of infertility treatment in women undergoing in vitro fertilization (IVF) procedure. For this project, we aim to obtain clinical data and follicular fluid samples from women undergoing IVF procedures. The ovarian follicular fluid samples will be used to purify granulosa cells for in vitro experiments. The remaining fluid will be used for hormone measurements. Our primary objective for this project is to establish molecular mechanism(s) by which irisin and other cytokines modulate ovarian steroid hormone production and thus may affect the outcomes of the IVF procedures.

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Reliability of the Freestyle Libre CGM in the inpatient setting during the COVID-19 surge

Principal Investigator: Renee Murray-Bachmann, Ed.D, MSN, RN, CDN, CDE
Co-Investigators: Simone Ashman, RN; Erin Donohoe, RN; Radhika Jaiswal, MD; Nicole Jie, RN; Seon Lewisholman ,RN; Swetha Murthi, MBBS; Alyson Myers, MD; Julie Rivera, RN, Leonid Poretsky, MD

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Sponsor: Abbott Labs
IRB#: 20-0455
Description: The FDA has provided an emergency waiver for the use of non-invasive patient monitoring technology, including continuous glucose monitors (CGM), in hospitals, so frontline health care providers (in hospitals) can remotely monitor patients with diabetes thus limiting exposure to COVID-19 and preserving critical personal protective equipment (PPE). The FreeStyle Libre 14-day system is a continuous glucose monitoring system consisting of a handheld reader (smart phone may be used) and a sensor worn on the back of the upper arm. In order to evaluate the reliability of the Freestyle Libre CGM for in-patient use, we propose a study which will examine the correlation between the libre CGM data and capillary blood glucose test – the current standard of care, taken by the Accuchek Inform II platform.

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Role of resistin in mediating obesity-induced breast cancer progression

Principal Investigator: Dimiter Avtanski, PhD

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Sub-Investigator: Leonid Poretsky, MD
Sponsor: Manhasset Women’s coalition for breast cancer research
No Human Subject Involvement
Description: In the context of cancer, epithelial to mesenchymal transition (EMT) induces the acquisition of cells with stem cell characteristics (cancer stem cells [CSCs]), which are believed to have the ability to initiate new tumors (tumor initiating cells [TICs]). Generally, TICs are characterized with high expression of cell surface protein CD44 and low or negative expression of CD24 (CD44+/CD24-/low). Resistin is an adipokine produced by the white adipose tissue (WAT) adipocytes and macrophages that plays a role in inflammation and insulin resistance. Circulating levels of resistin are increased in obesity. Preliminary reports suggest that resistin is associated with cancer progression and increases the metastatic potential of cancer cells. In this project we aim to investigate the effect of resistin on EMT and stem cell-like features in breast cancer cells, and the potential involvement of CAP1 in these processes. We hypothesize that resistin increases breast cancer aggressiveness by inducing EMT and appearance of stem-like features, and that this effect may depend on activation of CAP1.

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Reproductive effects of irisin

Principal Investigator: Leonid Poretsky, MD

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Sub-Investigator: Dimitar Avtanski, PhD
Sponsor: Friedman Diabetes Institute
Description: In this study, we are investigating how irisin may impact the hypothalamus-pituitary-gonadal axis by its direct effects on the pituitary and the ovary. The project involves human subjects and in vitro systems and is in collaboration with colleagues from the Northwell IVF facility in Manhattan.

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Shire – Paradighm (Physicians Advancing Disease Knowledge in Hypoparathyroidism): A Registry for Subjects with Chronic Hypoparathyroidism

Principal Investigator: Natalie Cusano, MD

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Co-Investigators: Emilia Liao, MD; Minghao Liu, MD; Jose Sanchez Escobar, MD; Agustin Busta, MD
Status: Site accepted; SIV completed; IA received
Sponsor: Shire Human Genetic Therapies, Inc. (Shire)
Description: The objectives of this registry are to characterize and describe the clinical course of chronic hypoparathyroidism under conditions of routine clinical practice. This includes, but is not limited to, treatments, symptoms, health-related quality of life (HRQoL), clinical outcomes, and comorbidity. In addition, to characterize and describe the long-term efficacy and safety profile of rhPTH (1-84) treatment in patients with chronic hypoparathyroidism under conditions of routine clinical practice. This includes, but is not limited to, long-term effects of rhPTH (1-84) on renal, eye, bone, cardiovascular, and other outcomes relevant for patients with hypoparathyroidism.

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Role of inflammatory cytokines in affecting the outcome from in vitro fertilization procedure

Principal Investigator: Dimiter Avtanski, PhD

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Sponsor: Katz Institute for Women’s Health Innovation Grants Program
Description: The purpose of this project is to explore how chronic inflammation modulates the success of infertility treatment in women undergoing in vitro fertilization (IVF) procedure. For this project, we aim to obtain clinical data and follicular fluid samples from women undergoing IVF procedures. The ovarian follicular fluid samples will be used to purify granulosa cells for in vitro experiments. The remaining fluid will be used for hormone measurements. Our primary objective for this project is to establish molecular mechanism(s) by which irisin and other cytokines modulate ovarian steroid hormone production and thus may affect the outcomes of the IVF procedures.

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Long Term Comparative Effectiveness of once weekly semaglutide versus standard of care in a real world adult US Population with type 2 diabetes – A randomized pragmatic clinical trial

Principal Investigator: Yael Harris, MD
Sub-Investigators: Leonid Poretsky, MD, Agustin Busta, MD

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Sponsor: Novo Nordisk
Status: Added as a satellite site
Description: The primary objective of this trial is to demonstrate superior long term effects of treatment with semaglutide compared to standard of care (SOC) when added to 1 or 2 oral antidiabetic medications on glycemic control and in need of treatment intensification in routine clinical practice in adult patients with T2DM

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Completed Projects

Obesity as a multifactorial disease: energy metabolism, insulin resistance, microbiome and endoscopic bariatric intervention in human obesity

Principal Investigators:  Leonid Poretsky, MD; Larry Miller, MD; Patrick Okolo, MD

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Sub-Investigators:  Dimiter Avtanski, PhD; Petros Benias, MD; Anil Vegesna, MD, MPH
Sponsor: New York State Department of Health, Empire Clinical Research Investigator Program (ECRIP)
Description: This project is comprised of three sub projects. The first project investigates the role of resistin/CAP1 interaction in mediating insulin resistance in obese individuals. The second project examines the efficacy of the endoscopic sleeve gastroplasty as an alternative to bariatric surgery and to assess hormonal changes that may occur as a result of the procedure and may predict and/or contribute to the post-procedure weight loss. The third project focuses on the evaluation of the pathophysiological defects in patients with and without Irritable Bowel Syndrome (IBS) and Small Intestinal Bacterial Overgrowth (SIBO) Correlating Microbiome with Individual’s Hormonal Profile.

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The Effects of Structured Outpatient Diabetes Program on the Hospital Readmission Rate in Patients with Diabetes

Principal Investigators:  Leonid Poretsky, MD

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Sub-Investigators:  Arpita Bhalodkar, MD; Renee Murray-Bachmann, RN
Sponsor: New York State Department of Health, Empire Clinical Research Investigator Program (ECRIP)
IRB#: HS16-0156-NH
Description: A structured outpatient diabetes management and education program delivered by a diabetes educator, social worker and a nutritionist that will provide individualized patient care pertaining to the specific clinical needs of the patients. The specific aims of this project are to determine if readmission rates for patients with diabetes as either primary or secondary diagnosis can be reduced with their enrollment in a structured diabetes management and education program; to determine if readmission rates in patients with primary diagnosis of diabetes can be reduced with this intervention; to determine if readmission rates in patients with secondary diagnosis of diabetes can be reduced with this intervention. For patients with secondary diagnosis of diabetes, to determine whether readmission rates depend on the primary diagnosis (e.g. congestive heart failure, infections etc.); to determine if there is a difference in readmission rates between patients with type 1 and type 2 diabetes.

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D2d: Vitamin D and type 2 diabetes. A multi-center, randomized, double-masked, placebo controlled, primary prevention clinical trial in participants at high risk for diabetes who will be followed for up to 4-years after randomization for new onset diabetes

Principal Investigator: Emilia Liao, MD

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Sub-Investigators: Leonid Poretsky, MD
Sponsor: National Institute of Diabetes and Digestive and Kidney diseases (NIDDK) & National Institutes of Health (NIH)
Description: The study’s main objective is to assess whether, in participants with pre-diabetes, oral daily vitamin D3 (cholecalciferol) supplementation reduces the rate of progression from pre-diabetes to diabetes.

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Toujeo LPS14347 Phase IV Study: A randomized, open-label, parallel group real world pragmatic trial to assess the clinical and health outcomes of Toujeo compared to commercially available basal insulins for initiation of therapy in insulin naïve patients with uncontrolled type 2 diabetes mellitus

Principal Investigator: Maria Pena

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Sub-Investigators: Leonid Poretsky, MD
Sponsor: Sanofi
Description: The primary objective of this project is to demonstrate clinical benefit of Toujeo in achieving individualized HEDIS HbA1c targets at 6 months without documented symptomatic hypoglycemia at any time of day from baseline to 6 months in uncontrolled insulin naïve patients with type 2 diabetes initiating basal insulin therapy in a real world setting. The secondary objective is to compare Toujeo to other commercially available basal insulins at 6 and 12 months after initiating insulin therapy in a real world setting.

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Advanced glycation end products and cardio-vascular complications in patients with diabetes

Principal Investigator: Leonid Poretsky, MD

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Sub-Investigator: Dimitar Avtanski, PhD; Varinder Singh, MD; Sarah Fishman, MD and Craig L. Basman, MD
Sponsor: Friedman Diabetes Institute
Description: In this pilot study, we will investigate the potential of the advanced glycation end products (AGEs) as early markers for the development of cardio-vascular complications in patients with T2DM. The project is in collaboration with the Departments of Cardiology and Endocrinology at Lenox Hill Hospital and Icahn School of Medicine at Mount Sinai Hospital in New York City.

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Improving Physician Understanding of Diabetes and Empathy Towards Patients with Diabetes

Principal Investigator: Sarah Fishman, MD

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Sponsor: Tandem Diabetes Care
Description: This project assesses the efficacy of using a mock insulin pump to improve physician empathy towards patients with diabetes. The second objective of this project is to assess the ability of resident physicians to adhere to a diabetic care plan and to improve physician understanding of the management of diabetes mellitus.

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A 26-week Randomized, Double-blind, Controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin compared to Empagliflozin, and Placebo in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on Dipeptidyl Peptidase 4 Inhibitor (DPP4(i)) With or Without Metformin

Principal Investigator: Leonid Poretsky, MD

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Sub-Investigators: Agustin Busta, MD; Maria Paliou, MD
Sponsor: Sanofi
Description: The primary objective of the study is to demonstrate the superiority of sotagliflozin 400 mg versus empaglifozin 25 mg versus placebo on hemoglobin A1c (HbA1c) reduction at Week 26 in patients with type 2 diabetes (T2D) who have inadequate glycemic control on a DPP4 (i) with or without metformin.

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FriedmanFellows.com

An annual fellowship program for highly talented investigators working under the mentorship of prominent scientists in diabetes, human nutrition and related topics was founded in 2000 by The Gerald J and Dorothy R Friedman NY Foundation for Medical Research.

*10/19 – U.S. News & World Report ranked us #9 out of 5,000 medical centers nationwide in Adult Diabetes and Endocrinology!