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History of Changes for Study: NCT04213651
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Diabetes Mellitus
Latest version (submitted September 2, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 27, 2019 None (earliest Version on record)
2 March 4, 2020 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 April 6, 2021 Contacts/Locations and Study Status
4 September 2, 2021 Study Status and Study Identification
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Study NCT04213651
Submitted Date:  December 27, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: ProgenaBiome-032
Brief Title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Diabetes Mellitus
Official Title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Diabetes Mellitus
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2019
Overall Status: Not yet recruiting
Study Start: January 2020
Primary Completion: January 2023 [Anticipated]
Study Completion: March 2023 [Anticipated]
First Submitted: December 23, 2019
First Submitted that
Met QC Criteria:
December 27, 2019
First Posted: December 30, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
December 27, 2019
Last Update Posted: December 30, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: ProgenaBiome
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.
Detailed Description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to diabetes mellitus
Open or close this module Conditions
Conditions: Diabetes Mellitus
Diabetes Mellitus, Type 2
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Case-Only
Time Perspective: Prospective
Biospecimen Retention: Samples With DNA
Biospecimen Description: Stool samples
Enrollment: 100 [Anticipated]
Number of Groups/Cohorts 1
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Diabetes Mellitus
Patients with diabetes mellitus
No intervention
There is no intervention for this study
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
[ Time Frame: Three years ]

Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized with diabetes mellitus
Open or close this module Eligibility
Study Population: Patients with diabetes mellitus
Sampling Method: Non-Probability Sample
Minimum Age:
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Sabine Hazan, MD
Telephone: 8053390549
Email: sabinehazan@aim.com
Central Contact Backup: Jordan Daniels, MS
Telephone: 8053390549
Email: msjordandaniels@gmail.com
Locations: United States, California
ProgenaBiome
Ventura, California, United States, 93003
Open or close this module IPDSharing
Plan to Share IPD: No
There is no plan to share IPD.
Open or close this module References
Citations:
Links:
Available IPD/Information:

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