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.

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

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