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Initial Clinical Evaluation of an Endoscopic Therapy for Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01927562
Recruitment Status : Active, not recruiting
First Posted : August 22, 2013
Last Update Posted : October 5, 2018
Sponsor:
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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
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
Study Start Date : August 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Duodenal Treatment Device: Fractyl Duodenal Remodeling System



Primary Outcome Measures :
  1. HbA1c [ Time Frame: 12 months ]
  2. Adverse Event Profile [ Time Frame: 12 months ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT01927562


Locations
Chile
INDISA
Santiago, Chile
Sponsors and Collaborators
Fractyl Laboratories, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fractyl Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT01927562     History of Changes
Other Study ID Numbers: C-10000
First Posted: August 22, 2013    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases