Initial Clinical Evaluation of an Endoscopic Therapy for Type 2 Diabetes

NCT ID: NCT01927562

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-13
• Study Completion Date: 2018-03-16

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.

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).

Conditions

Type II Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fractyl Duodenal Remodeling System

Intervention Type: DEVICE

Interventions

Fractyl Duodenal Remodeling System

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 28 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fractyl Health Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leonard R Gomez, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Clinico De La Obesidad

Locations

INDISA

Santiago, , Chile

Countries

Chile

References

Rajagopalan H, Cherrington AD, Thompson CC, Kaplan LM, Rubino F, Mingrone G, Becerra P, Rodriguez P, Vignolo P, Caplan J, Rodriguez L, Galvao Neto MP. Endoscopic Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes: 6-Month Interim Analysis From the First-in-Human Proof-of-Concept Study. Diabetes Care. 2016 Dec;39(12):2254-2261. doi: 10.2337/dc16-0383. Epub 2016 Aug 12.

Reference Type: DERIVED

PMID: 27519448 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

C-10000

Identifier Type: -

Identifier Source: org_study_id