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Initial Clinical Evaluation of an Endoscopic Therapy for Type 2 Diabetes | Clinical Trials | Clareo Health

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Initial Clinical Evaluation of an Endoscopic Therapy for Type 2 Diabetes

Evaluation of the Fractyl Duodenal Remodeling System for the Treatment of Type 2 Diabetes

NCT01927562•Fractyl Health Inc.

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).

Eligibility

Age

28 - 75 years

Sex

ALL

Healthy Volunteers

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
+15 more criteria

Locations (1)

INDISA

Santiago, Chile

Key Dates

Start Date

July 13, 2013

Primary Completion Date

April 7, 2017

Completion Date

March 16, 2018

Last Updated

February 14, 2024

Enrollment

ACTUAL participants

Conditions

Type II Diabetes

Interventions

Fractyl Duodenal Remodeling System

DEVICE

Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors

NCT07350694

Diabetes Type 2Type II Diabetes Mellitus

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 14, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Initial Clinical Evaluation of an Endoscopic Therapy for Type 2 Diabetes

Inclusion Criteria

Exclusion Criteria

Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors

Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus

Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors [EMPOWER-D]

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