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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04905485
• Other study ID #: V136 (VIOME-001 v5.0)
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 21, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2021
• Source: Viome
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2912
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2
• Glucose Intolerance
• Pre-diabetes
• Prediabetic State

Intervention

Behavioral:
• VIOME Precision Nutrition Program
Precision diet and supplement recommendations based on participants' microbiome results.

Locations

Country	Name	City	State
United States	Viome Research Institute	Bothell	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Viome

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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