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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01927562
Other study ID # C-10000
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 13, 2013
Est. completion date March 16, 2018

Study information

Verified date February 2024
Source Fractyl Health Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date March 16, 2018
Est. primary completion date April 7, 2017
Accepts healthy volunteers No
Gender All
Age group 28 Years to 75 Years
Eligibility 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

Study Design


Intervention

Device:
Fractyl Duodenal Remodeling System


Locations

Country Name City State
Chile INDISA Santiago

Sponsors (1)

Lead Sponsor Collaborator
Fractyl Health Inc.

Country where clinical trial is conducted

Chile, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changed in Mixed Meal Tolerance From Baseline to 3 Months Improvement in fasting plasma glucose based on Mixed Meal Tolerance Test between baseline and 3 months 3 months
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