Back to resultsDeveloping a Model to Better Predict Diabetes and/or Risk of Developing Diabetes
Primary Purpose
Diabetes Type 2, Diabetes, Pre-diabetes
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VIOME Precision Nutrition Program
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Type 2 focused on measuring Viome, Diabetes Type 2, Diabetes, Pre-diabetes, VPNP, Nutrition, Supplements, Precision
Eligibility Criteria
Inclusion Criteria:
- Viome customer
- GI test collected at home using Viome test kit
- US citizen
- 18+ years old
- Is not participating in any other Viome study
- Must have answered the following on-boarding question with the indicated answer:
"Do you or did you ever have diabetes or prediabetes?"
- Signed and dated informed consent prior to any trial-specific procedures are performed
- Able to speak and read English
- Willing and able to follow the trial instructions
Exclusion Criteria:
- Unable/unwilling to complete the informed consent form and the questionnaires
Sites / Locations
- Viome Research Institute
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intervention
Arm Description
All participants received the intervention in this trial. They received recommendations on their diets and supplements based on their results of microbiome expression.
Outcomes
Primary Outcome Measures
Difference in VIOME's Type 2 diabetes risk score
"Type 2 diabetes risk score" is computed using Viome's molecular data from stool and HBA1C level self reported. The risk score is 1-100. 1 Indicates a low chance of developing T2D and 100 indicates a high chance of developing T2D.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04905485
Brief Title
Developing a Model to Better Predict Diabetes and/or Risk of Developing Diabetes
Official Title
Developing a Model to Better Predict Diabetes and/or Risk of Developing Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Viome
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Participants who were previously Viome costumers who signed informed consent to participate and self reported type 2 diabetes or pre-diabetes were enrolled. They provided stool samples to VIOME and were provided with precision diet and supplement recommendations. The information obtained from this study is used to train a model to predict diabetes and/or risks of developing diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2, Diabetes, Pre-diabetes
Keywords
Viome, Diabetes Type 2, Diabetes, Pre-diabetes, VPNP, Nutrition, Supplements, Precision
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants all received diet and supplement recommendations based on their microbiome results.
Masking
None (Open Label)
Allocation
N/A
Enrollment
2912 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Other
Arm Description
All participants received the intervention in this trial. They received recommendations on their diets and supplements based on their results of microbiome expression.
Intervention Type
Behavioral
Intervention Name(s)
VIOME Precision Nutrition Program
Other Intervention Name(s)
VPNP
Intervention Description
Precision diet and supplement recommendations based on participants' microbiome results.
Primary Outcome Measure Information:
Title
Difference in VIOME's Type 2 diabetes risk score
Description
"Type 2 diabetes risk score" is computed using Viome's molecular data from stool and HBA1C level self reported. The risk score is 1-100. 1 Indicates a low chance of developing T2D and 100 indicates a high chance of developing T2D.
Time Frame
~3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Viome customer
GI test collected at home using Viome test kit
US citizen
18+ years old
Is not participating in any other Viome study
Must have answered the following on-boarding question with the indicated answer:
"Do you or did you ever have diabetes or prediabetes?"
Signed and dated informed consent prior to any trial-specific procedures are performed
Able to speak and read English
Willing and able to follow the trial instructions
Exclusion Criteria:
Unable/unwilling to complete the informed consent form and the questionnaires
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guruduth Banavar, PhD
Organizational Affiliation
Viome
Official's Role
Principal Investigator
Facility Information:
Facility Name
Viome Research Institute
City
Bothell
State/Province
Washington
ZIP/Postal Code
98011
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Developing a Model to Better Predict Diabetes and/or Risk of Developing Diabetes
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