Skip to main content

C-40000

NCT03653091

C-40000

Associated Conditions

Type 2 Diabetes

Principal Investigator

Sponsor

Fractyl Laboratories

Study Status: Active - Open to Enrollment
Study Name: C-40000
Study Focus: A1c and Glucose
Study Contact: To learn more, please call 1-877-854-8475 or fill out the Contact us form.
Study Purpose: The purpose of this study is to learn more about the use of the RevitaTM System for the treatment of Type 2 diabetes.

To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if you meet the following criteria:

  • 28-65 years of age
  • BMI 28-40 kg/m2
  • Type II Diabetes (at least three years)
  • Prescribed with 2 OADs, one of them Metformin

Study Duration: up to 60 weeks

Study Commitment:

  • 3 Screening visits
  • Up to 11 Outpatient visits (including procedure visit)
  • Up to 10 Phone calls

Study Procedures:

  • Physical exam, vital signs, height, and weight, EKG, fasting labs
  • IV insertion
  • Multiple blood draws
  • Phone calls
  • Urine Screen
  • Pregnancy Test
  • MRI
  • Endoscopy (Duodenal Mucosal Resurfacing [DMR] or Sham procedure)
  • Biopsy during endoscopy at week 24 (only DMR patients)
  • Questionnaires
  • Diary completion


Compensation offered up to $ 2,325 to cover visit related expenses.

This study is being conducted under the direction of Dr. Steven Smith at 301 East Princeton Street, Orlando, Florida 32804.

This study is currently enrolling.