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.

Exenatide Study of Cardiovascular Event Lowering Trial

  • Age 18 years or older
  • Patients with Type 2 Diabetes
  • HgbA1c 6.5% - 10% within 3 months of screening
  • Up to three oral anti-hypertension agents or insulin with up to two oral anti-hypertension agents

Study Contact: Barb Heaton - 216.444.9612

Cortendo - An open label study to assess the safety and efficacy of COR-003 (2S, 4R-Ketoconazole) in the treatment of endogenous Cushing's syndrome

Inclusions:

  • Confirmed diagnosis of persistent or recurrent CS (with or without therapy) or newly diagnosed disease, if they are not candidates for surgery
  • Subjects on treatment for CS for whom treatment has been inadequate or not well tolerated
  • 12-lead ECG's show no acute ischemia or clinically significant abnormality needing medical intervention
  • Exclusion criteria-History of malignancy & subjects treated with radiation within the previous 4 years or > 4 years with evidence of improvement in their disease within 6 months prior to screening

Study Contact: Ana Surckla - 216.444.3955

D2d Study - Randomized (1:1) double-masked, placebo-controlled, parallel-group, primary prevention clinical trial with 2 arms (oral daily vitamin D vs. placebo) in participants at high risk for diabetes (with pre-diabetes) who will be followed for approx. 4 years after randomization for incident diabetes

Inclusions:

  • Age 30 or greater
  • Fasting plasma glucose 100-125 mg/dl
  • 2 hour plasma glucose 140-199 mg/dl
  • HgbA1c 5.7-6.4%
  • BMI 24-42 kg/m2

Study Contact: Ana Surckla - 216.444.3955

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: Denise Rose - 216.444.8824

Mind Field Solutions: Prospective Validation of Predictive Tool - A survey about diabetes and health in general that may be useful in helping you and your healthcare provider better manage your diabetes

Inclusion:

  • Type 2 diabetic
  • A1C below 9%

Exclusion:

  • Patients under age 18
Study Contact: Alyssa Mackie - 216.444.8942

REAL 1: A multicenter multinational, randomized, parallel-group, placebo-controlled, (double blind) active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily norditropin flex pro in adults with growth hormone deficiency for 35 weeks with a 53 week extension period

Inclusion:

  • Growth hormone deficiency (GHD) fulfilling with one of the following criteria:
  1. Adult onset: subjects diagnosed with GHD, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy or traumatic brain injury (TBI)
  2. Childhood onset: Subjects who were growth hormone deficient during childhood as a result congenital genetic, acquired, or idiopathic causes
  • Confirmed diagnosis of adult growth hormone deficiency with an insulin tolerance test or glucagon test

Exclusion:

  • Use of injectable anti-diabetic agents
  • Inability to undergo DXA whole body scanning due to body weight or size which exceeds the limit of the DXA scanner

Study Contact: Barb Heaton - 216.444.9612