A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Diabetes Mellitus

NCT ID: NCT04213651

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-02

Study Completion Date

2030-07-31

Brief Summary

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This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Detailed Description

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The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to diabetes mellitus

Conditions

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Diabetes Mellitus Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetes Mellitus

Patients with diabetes mellitus

No intervention

Intervention Type OTHER

There is no intervention for this study

Interventions

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No intervention

There is no intervention for this study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study

a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
2. Male or female of all ages
3. Diagnosis of diabetes mellitus based on blood glucose and/or hemoglobin A1C

Exclusion Criteria

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ProgenaBiome

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sabine Hazan, MD

Role: PRINCIPAL_INVESTIGATOR

ProgenaBiome

Locations

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ProgenaBiome

Ventura, California, United States

Site Status

Countries

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United States

Other Identifiers

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PRG-032

Identifier Type: -

Identifier Source: org_study_id

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