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.

CORT125134 - Phase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing's Syndrome

Inclusion:

  • Between the ages of 18-75
  • Confirmed diagnosis of endogenous Cushing’s syndrome
  • Requires Medical treatment of Hypercortisolemia
  • Meets one of the following: Diabetes type II, Hypertension or Impaired Glucose tolerance.
  • Females patients of childbearing potential must be willing to use highly effective method of contraception.

Exclusion:

  • Has a non-endogenous source of Hypercortisolemia or Pseudo-Cushing’s syndrome.
  • Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
  • Has Stage > or =4 renal failure (GFR <-29>
  • Is currently receiving chemotherapy for a tumor related to Cushing’s syndrome
  • Is planning surgery or radiation therapy for Cushing’s during study
  • Lactating
  • HIV or hepatitis B or C infection

Study Contact: Ana Surckla; 216.444.3955

OOC-ACM-303 - A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy and safety of Octreotide Capsules In Patients Who Previously Tolerated and Demonstrated Biocehemical Control on Injectable Somatostatin Receptor Ligands (SRL) Treatment

Inclusion:

  • At least 18 years old
  • Diagnosis of Acromegaly with above normal increase in hormone levels (IGF-1 levels)
  • Insulin treatment for at least 12 months, but for less than 96 months
  • Received one type of injection (octreotide or lanreotide but not pasireotide) for at least 6 months

Exclusion:

  • Patients taking injections of long-acting SRLs off label (unlabeled doses or dosing interval. e.g. 60 or 90 mg lanreotide every 8 weeks or 30 mg octreotide every 6 or 8weeks).
  • Patients who previously participated in CH-ACM-01 or OOC-ACM-302 (MPOWERED).
  • Symptomatic cholelithiasis.
  • Conventional or stereotactic Radiotherapy any time in the past.
  • Undergone pituitary surgery within six months prior to screening or have elective pituitary surgery (or other elective surgery that may affect compliance with protocol

Study Contact: Dana Crowe; 216.444.8824

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: Blair Martin; 216.444.7751

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