Clinical Studies:

We use data from mice to inspire human translational studies. Our lab collaborates with world-class clinical researchers to design studies that advance our knowledge of human metabolism. We serves as a translational hub for multiple clinical trials testing the effects of specialized dietary patterns (e.g., very low carbohydrate, ketogenic diets), added sugars (e.g., high fructose corn syrup), and anti-cancer therapies (e.g., PI3K inhibitors) on the endocrine system of subjects with cancer and those with metabolic syndromes like obesity and diabetes.

1. To identify novel cachexia mediators in patients with NSCLC

In collaboration with members of the Division of Thoracic Surgery, Medical Oncology, and the Meyer Cancer Center, we are collecting serum and skeletal muscle tissue from patients with NSCLC.  We use targeted proteomic analysis on the serum and computed tomography measures of skeletal muscle mass to identify novel factors that correlate with cachexia.

2. To develop clinical algorithms to care for patients with cachexia

Roughly 80% of patients with advanced cancer are experiencing cachexia. Currently, there is no widely accepted approach to care for these people. At Weill Cornell Medicine, we have a specialized cachexia clinic where we are developing clinical care pathways. Studies are ongoing to determine if our approach helps to reverse weight loss.

3. To Evaluate the Metabolomic and Tissue Effects of a Ketogenic Diet in Newly Diagnosed Overweight or Obese Endometrial Cancer Patients

This is a feasibility study done in collaboration with Memorial Sloan Kettering Cancer Centerand the Clinical Translational Science Center at Weill Cornell. Here we are studying the effects of the classic ketogenic diet on women with endometrial cancer in the neoadjuvant setting.

4. To evaluate the PI3K Inhibitor, Copanlisib, in Combination with a Ketogenic Diet in the Treatment of Patients with Relapsed or Refractory Lymphoma or Endometrial Cancer

This is a pilot phase Ib/II study done in collaboration with Columbia University Medical Center, Memorial Sloan Kettering Cancer Center, and the Clinical Translational Science Center at Weill Cornell.  Here we are testing if a PI3K inhibitor improves outcomes when paired with a classic ketogenic diet.

5. Targeting Insulin Feedback to Enhance Alpelisib (TIFA trial)

This is a prospective randomized, parallel design, phase II study to test the efficacy and safety of 3 interventions targeting insulin feedback during alpelisib therapy. Here we are testing if anti-glycemic therapies can prevent adverse effects and improve efficacy of a PI3K inhibitor.

6. Next Generation Sequencing for Diabetes and Metabolic Diseases

Patients with type 2 diabetes are diagnosed and treated similarly despite enormous heterogeneity in this population. In this study, we seek to advance Precision Medicine in the fields of diabetes and other metabolic diseases. Our goals are to (1) use whole genome sequencing to study the genetic basis of diabetes in order to improve diagnosis, prevention, and treatment; (2) identify genomic biomarkers that predict β cell function and (3) hepatic metabolism.

7. A Pilot Study to Assess Fructose Uptake by Primary Human Colorectal Tumors

This study is designed to investigate the specific uptake of fructose by human colorectal tumors. In this study, subjects with CRC undergoing surgery will receive an oral sugar solution containing fructose or xylose prior to surgery. The tumor will then be resected, and a portion of the tissue will be used to measure the abundance of fructose and xylose. We hypothesize that the tumors will take up fructose but not xylose. We will compare the uptake of the tumor with the uptake into normal tissues like the adjacent intestinal epithelium and smooth muscle, and the liver. This proposal will confirm that human CRC tumors can directly absorb dietary sugars, which has never been demonstrated.