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Active 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:  Dimitar Avtanski, PhD; Petros Benias, MD; Bani Roland, MD
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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Role of resistin in obesity-induced insulin resistance

Principal Investigator: Dimitar Avtanski, PhD

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Sub-Investigator: Leonid Poretsky, MD
Sponsor: Friedman Diabetes Institute
Description: The goal of this project is to investigate resistin interactions with CAP1 and to understand the molecular mechanisms behind the peripheral tissue insulin resistance. To reach this goal, we are implementing mouse models, human subjects and in vitro systems as well as we are working closely with our collaborators from Lenox Hill and Northern Westchester hospitals in New York City, The Feinstein Institute for Medical Research in Manhasset, NY, the University of Maryland and The Johns Hopkins University Schools of Medicine in Baltimore, MD and others.

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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 Lenox Hill Hospital and Weill Medical College of Cornell University in New York City.

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

Principal Investigator: Leonid Poretsky, MD

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Sub-Investigator: Arpita Bhalodkar, MD
Sponsor: New York State Department of Health (NYS DOH) Empire Clinical Research Investigator Program (ECRIP)
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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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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Cushing’s LCI699: A Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing’s disease

Principal Investigator: John Boockvar, MD

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Sub-Investigator: Leonid Poretsky, MD
Sponsor: Novartis
Description: The study aims to confirm efficacy and safety of osilodrostat for the treatment of patients with Cushing’s disease (CD) who are candidates for medical therapy. The primary objective is to demonstrate the superiority of osilodrostat compared to placebo in achieving a complete response at Week 12. The secondary objective is to assess the complete response rate in both arms combined at Week 36 in patients receiving osilodrostat treatment.

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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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A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Effects of Sotagliflozin on Cardiovascular and Renal Events in Patients with Type 2 Diabetes, Cardiovascular Risk Factors and Moderately Impaired Renal Function

Principal Investigator: Leonid Poretsky, MD

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Sub-Investigators: Agustin Busta, MD; Maria Paliou, MD
Sponsor: Sanofi
Description: The study’s primary objective is to demonstrate that sotagliflozin is non-inferior to placebo on the composite endpoint of CV death, non-fatal MI or non-fatal stroke (3-point MACE) and reduces the composite endpoint of CV death or Hospitalization for Heart Failure (HHF). The secondary objective of the study is to assess the safety and tolerability of sotagliflozin in patients with T2D, Cardiovascular Risk Factors and moderately impaired renal function.

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Active Projects – Closed to Enrollment

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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Completed Projects

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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Cushing’s SOM230: A multi-center, randomized, open-label, Phase IV study to investigate the management of pasireotide-induced hyperglycemia with incretin based therapy or insulin in adult patients with Cushing’s disease or acromegaly

Principal Investigator: John Boockvar, MD

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Sub-Investigators: Leonid Poretsky, MD
Sponsor: Novartis
Description: The primary objective is to evaluate the effect of treatment with incretin based therapy vs. insulin on the 16-week glycemic control in patients with Cushing’s disease or acromegaly who develop or worsen hyperglycemia on pasireotide, and cannot be controlled by metformin alone or other background anti-diabetic treatments.

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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.