Developing a Model to Better Predict Diabetes and/or Risk of Developing Diabetes

NCT ID: NCT04905485

Last Updated: 2021-06-08

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

2912 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-21

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Type 2 Diabetes Pre-diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participants all received diet and supplement recommendations based on their microbiome results.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention

All participants received the intervention in this trial. They received recommendations on their diets and supplements based on their results of microbiome expression.

Group Type OTHER

VIOME Precision Nutrition Program

Intervention Type BEHAVIORAL

Precision diet and supplement recommendations based on participants' microbiome results.

Interventions

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VIOME Precision Nutrition Program

Precision diet and supplement recommendations based on participants' microbiome results.

Intervention Type BEHAVIORAL

Other Intervention Names

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VPNP

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Viome

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guruduth Banavar, PhD

Role: PRINCIPAL_INVESTIGATOR

Viome

Locations

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Viome Research Institute

Bothell, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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V136 (VIOME-001 v5.0)

Identifier Type: -

Identifier Source: org_study_id

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