Overview

Overview

The physicians and scientists in the Endocrinology & Metabolism Institute are committed to doing research that advances the treatment of diseases and improves the care of patients. These studies include investigations of new treatments for diabetes and other endocrine disorders, newer surgical approaches to parathyroid and thyroid conditions, radio-frequency ablation of liver tumors, and surgical and medical management of obesity.

Should you desire any further information about our research program or interested in participating in one of our research studies, please contact:

Blair Martin - Research Coordinator
martinb10@ccf.org
216.444.7551

Current Research

Current Research

Brief descriptions of our research projects that are actively enrolling new subjects are listed below.

ENHANCE: Evaluation of the Thyroid FNA Genomics Signature

Inclusion:

  • No more than 2 nodules greater than 1 cm in diameter in the thyroid lobe in which FNA was performed
  • Arm I: Must have had a thyroid FNA testing and surgery is being recommended or thyroid resection has been completed
  • Arm II: Thyroid FNA testing resulted in a benign diagnosis and 18 months of follow-up documenting continued benign nodule status

Exclusion: Patients will not be eligible for inclusion in the study if:

  • The patient did not have thyroid FNA performed
  • GEC/molecular sample was not sent to Veracyte for analysis

Study Contact: Karim Kheniser – 216.444.8942

Corcept – FKBP5-700: Prospective, Non-interventional Clinical Study of Biomarker Expression in Patients with ACTH-Dependent Cushing's Syndrome Before and After Surgery

Inclusions:

  • Age 18 years or older
  • Has a documented diagnosis of ACTH-dependent, endogenous Cushing’s syndrome and is scheduled for curative surgery

Exclusions:

  • Plans for pre-operative and/or intra-operative use of glucocorticoid (“steroid cover”)
  • Oral, inhaled, IV or topical glucocorticoids 2 weeks prior to first specimen collection
  • Use of Mifepristone 6 weeks prior to first specimen collection and/or during the study period
  • Oral contraceptives or hormonal replacement therapy
  • Pregnancy or breastfeeding

Study Contact: Blair Martin – 216.444.7551

Functional Medicine: Assessment of Diabetes Control, Cost of Care, and Quality of Life Utilizing a Functional Medicine Approach vs. Usual Care

Inclusion:

  • Ages 21 to 75
  • Diagnosis of Type 2 Diabetes
  • Insulin treatment for at least 12 months, but for less than 96 months
  • Total daily insulin dose ≤ 150 units

Exclusion:

  • C peptide < 0.8 ng/ml
  • Use of Insulin Pump for diabetes treatment
  • HbA1c > 12%
  • History of Diabetic Ketoacidosis (DKA)
  • Pregnancy or breastfeeding
  • Use of Coumadin (warfarin)

Study Contact: Ana Surckla – 216.444.3955

Pioneer: Cardiovascular outcomes - A trial investigating the cardiovascular safety of oral semaglutide in subjects with type 2 diabetes

Inclusion:

  • Male or female diagnosed with Type 2 Diabetes
  • Age ≥ 50 years at screening and at least one of the below conditions
    • Prior myocardial infarction
    • Prior stroke or transient ischaemic attack(TIA)
    • Prior coronary, carotid or peripheral arterial revascularization

or

  • Age ≥ 60 years at screening and at least one of the below risk factors
    • Microalbuminuria or proteinuria
    • Hypertension and left ventricular hypertrophy by ECG or imaging
    • Left ventricular systolic or diastolic dysfunction by imaging

Exclusion:

  • Current or previous (within 90 days prior to screening) treatment with any GLP-1 receptor agonist, DPP-4 inhibitor or pramlintide
  • Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC)
  • History of pancreatitis (acute or chronic)
  • History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)

Study Contact: Nikki Breslaw – 216.584.7864

CARAT: Canagliflozin vs. Placebo for Post BAriatric Patients with PeRsistent Type 2 DiAbeTes

Inclusion:

  • Post-RYGB and SG patients who underwent surgery <1 and <15 years ago, in the Cleveland surrounding area
  • 20-75 years of age
  • DM2 diagnosis (history, medication usage, biochemical criteria) prior to and after surgery; after surgery, defined by a single HbA1c of greater or equal to 6.5% at consent and screening
  • Metformin patients must have an HbA1c greater than or equal to 6.5% but less than or equal to 10% at randomization; for diet controlled patients (i.e. not on any T2D medication), HbA1c must be greater than or equal to 6.5% at randomization
  • Patient reporting of improvement in T2D status or objective improvements in T2D status at any time post-surgery
  • eGFR ≥ 60mL/min prior to randomization
  • Patients taking an anti-diabetic medication, except insulin, are eligible and must agree to washout for 8 weeks prior to the randomization visit

Exclusion:

  • Type 1 diabetes indicated by history of diabetic ketoacidosis and lake of remission in response to bariatric surgery
  • Other post bariatric procedures (banding, duodenal switch, biliopancreatic diversion)
  • Current use of insulin
  • End organ diabetic complications (renal failure, cardiomyopathy, severe neuropathy/foot ulcers)
  • Documented severe or unstable depression/anxiety or eating disorder that would not enable patient to adhere to anti-diabetic treatment
  • Clinical contraindications to use canagliflozin, i.e., history of bladder cancer, Child-Pugh class C

Study Contact: Tracy Tomaro – 216.445.9278

Millendo – ATR-101-301: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of ATR-101 for the Treatment of Cushing’s Syndrome

Inclusions:

  • Men and women 18-80 years of age (inclusive) at screening

Additionally, subjects must have a confirmed diagnosis of endogenous Cushing’s documentation at any time of ONE of the following three criteria:

  • Diagnosis of pituitary Cushing’s syndrome
  • Diagnosis of adrenal Cushing’s syndrome
  • Diagnosis of ectopic ACTH as the cause of Cushing’s syndrome

Subjects with a history of prior pituitary surgery must be at least 6 months post-surgery at the time of the screening visit

Exclusions:

  • Pseudo-Cushing's syndrome, cyclic Cushing's syndrome or current iatrogenic Cushing's syndrome
  • Subjects who are considered candidates for surgical treatment of Cushing's Syndrome
  • Radiotherapy of the pituitary within 1 year prior to or during screening
  • History of gastric or small intestinal surgery
  • Pregnancy or breastfeeding

Study Contact: Ana Surckla – 216.444.3955