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

NCT04905485 | Unknown

• 1 other identifier: V136 (VIOME-001 v5.0)
• Study Type: interventional
• Target: 2,912
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Type 2; Diabetes; Pre-diabetes

Keywords

Viome; Diabetes Type 2; Diabetes; Pre-diabetes; VPNP; Nutrition; Supplements; Precision

Outcome Measures

Primary Outcomes (1)

• 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.

  ~3 months

Study Arms (1)

Intervention

OTHER

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

Behavioral: VIOME Precision Nutrition Program

Interventions

VIOME Precision Nutrition Program BEHAVIORAL

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

Also known as: VPNP

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Viome customer
• GI test collected at home using Viome test kit
• US citizen
• + 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

You may not qualify if:

• Unable/unwilling to complete the informed consent form and the questionnaires

Sponsors & Collaborators

• Viome: lead

Study Sites (1)

Viome Research Institute

Bothell, Washington, 98011, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Glucose Intolerance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Study Officials

• Guruduth Banavar, PhD

  Viome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants all received diet and supplement recommendations based on their microbiome results.

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: May 27, 2021
• Study Start: May 21, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)