NCT01927562

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 13, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2018

Completed
2 years until next milestone

Results Posted

Study results publicly available

March 24, 2020

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

3.7 years

First QC Date

August 20, 2013

Results QC Date

February 7, 2020

Last Update Submit

February 12, 2024

Conditions

Type II Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Duodenal Treatment

EXPERIMENTAL

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

Interventions

Fractyl Duodenal Remodeling SystemDEVICE
Duodenal Treatment

Eligibility Criteria

Age28 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Participants diagnosed with Type I Diabetes or with a history of ketoacidosis
  • Participants using insulin for more than 12 months
  • Participants with probable insulin production failure (defined as fasting C Peptide serum \<1ng/mL)
  • Participants that have known autoimmune disease as evidenced by a positive anti glutamic acid decarboxylase (GAD) blood test
  • 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
  • Participants with iron deficiency anemia - either currently or in their history
  • Participants with current symptomatic hypocalcemia or vitamin D deficiency (routine calcium and/or vitamin D supplementation would not be excluded)
  • Participants with or a history of abnormalities of the GI tract preventing endoscopic access to the duodenum,
  • Participants with symptomatic gallstones or kidney stones at the time of screening
  • Participants with a history of pancreatitis
  • Participants with an active systemic infection
  • Participants with or a history of coagulopathy, upper gastro-intestinal bleeding c conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
  • Participants with celiac disease
  • Participants with active malignancy. Those who have had remedial treatment and/or are cancer free for 5 years can be enrolled
  • Participants with known active hepatitis or active liver disease
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INDISA

Santiago, Chile

Location

Related Publications (1)

  • 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.

    PMID: 27519448DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Sarah Hackett
Organization
Fractyl
shackett@fractyl.com
617-596-9522

Study Officials

  • Leonard R Gomez, MD

    Centro Clinico De La Obesidad

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2013

First Posted

August 22, 2013

Study Start

July 13, 2013

Primary Completion

April 7, 2017

Study Completion

March 16, 2018

Last Updated

February 14, 2024

Results First Posted

March 24, 2020

Record last verified: 2024-02

Locations

CL(1)