Working… Menu

Initial Clinical Evaluation of an Endoscopic Therapy for Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01927562
Recruitment Status : Completed
First Posted : August 22, 2013
Results First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Information provided by (Responsible Party):
Fractyl Laboratories, Inc.

Brief Summary:
The purpose of this study is to assess the safety and feasibility of the Fractyl Duodenal Remodeling System for the treatment of patients with poorly controlled Type 2 Diabetes.

Condition or disease Intervention/treatment Phase
Type II Diabetes Device: Fractyl Duodenal Remodeling System Not Applicable

Detailed Description:
The purpose of this protocol is to evaluate the initial safety profile of the Fractyl System and its effect on participants with Type 2 Diabetes. This will be determined through the monitoring of adverse events and outcome measures including Mixed Meal Tolerance Test (MMTT).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Fractyl Duodenal Remodeling System for the Treatment of Type 2 Diabetes
Actual Study Start Date : July 13, 2013
Actual Primary Completion Date : April 7, 2017
Actual Study Completion Date : March 16, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Duodenal Treatment
The Duodenal Remodeling procedure utilizes both a trans-oral over the wire and endoscopic approach to minimally invasively ablating and remodeling the duodenum.
Device: Fractyl Duodenal Remodeling System

Primary Outcome Measures :
  1. Changed in Mixed Meal Tolerance From Baseline to 3 Months [ Time Frame: 3 months ]
    Improvement in fasting plasma glucose based on Mixed Meal Tolerance Test between baseline and 3 months

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   28 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Participants Age > 28 years and ≤ 75 years
  2. Male or Female
  3. Participants with Type 2 Diabetes who are treated for ≤ 10 years and are on stable oral diabetic medications for a minimum of 3 months
  4. Participants with an HbA1c > 7.5 and ≤ 10.0%
  5. Participants with a BMI > 24 and < 40
  6. Participants willing to comply with study requirements and able to understand and comply with informed consent
  7. Participants who have signed an informed consent form

Exclusion Criteria:

  1. Participants diagnosed with Type I Diabetes or with a history of ketoacidosis
  2. Participants using insulin for more than 12 months
  3. Participants with probable insulin production failure (defined as fasting C Peptide serum <1ng/mL)
  4. Participants that have known autoimmune disease as evidenced by a positive anti glutamic acid decarboxylase (GAD) blood test
  5. Participants requiring prescription anticoagulation therapy and/or dual anti-platelet therapy including aspirin who cannot discontinue their medication for 14 days before and 14 days after the procedure
  6. Participants with iron deficiency anemia - either currently or in their history
  7. Participants with current symptomatic hypocalcemia or vitamin D deficiency (routine calcium and/or vitamin D supplementation would not be excluded)
  8. Participants with or a history of abnormalities of the GI tract preventing endoscopic access to the duodenum,
  9. Participants with symptomatic gallstones or kidney stones at the time of screening
  10. Participants with a history of pancreatitis
  11. Participants with an active systemic infection
  12. Participants with or a history of coagulopathy, upper gastro-intestinal bleeding c conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
  13. Participants with celiac disease
  14. Participants with active malignancy. Those who have had remedial treatment and/or are cancer free for 5 years can be enrolled
  15. Participants with known active hepatitis or active liver disease
  16. Participants emotionally unstable or who exhibit psychological characteristics which, in the opinion of the Investigator, make the participant a poor candidate for clinical trial participation
  17. Participants with previous GI surgery that could affect the ability to treat the duodenum such as participants who have had a Bilroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions
  18. Participants unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatment through 2 weeks post procedure phase
  19. Participants receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications
  20. Participant with a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
  21. Participants with active and uncontrolled gastroesophageal reflux disease (GERD) defined as grade II esophagitis or greater
  22. Participants with active illicit substance abuse or alcoholism
  23. Participants participating in another ongoing investigational clinical trial
  24. Participants taking corticosteroids or drugs known to affect GI motility (i.e. Reglan)
  25. Participants who are not potential candidates for duodenal exclusion surgery or general anesthesia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01927562

Layout table for location information
Santiago, Chile
Sponsors and Collaborators
Fractyl Laboratories, Inc.
Layout table for investigator information
Principal Investigator: Leonard R Gomez, MD Centro Clinico De La Obesidad
  Study Documents (Full-Text)

Documents provided by Fractyl Laboratories, Inc.:
Statistical Analysis Plan  [PDF] February 21, 2020
Study Protocol  [PDF] March 10, 2016

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Fractyl Laboratories, Inc. Identifier: NCT01927562    
Other Study ID Numbers: C-10000
First Posted: August 22, 2013    Key Record Dates
Results First Posted: March 24, 2020
Last Update Posted: March 24, 2020
Last Verified: March 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases