Diabetes Type 2NCT04905485
Developing a Model to Better Predict Diabetes and/or Risk of Developing Diabetes
A study testing VIOME Precision Nutrition Program in people with Diabetes Type 2 and Diabetes, run by Viome at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Type 2, Diabetes, Pre-diabetes
- What is being tested?
- VIOME Precision Nutrition Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,912 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- "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
Who cannot join
- Unable/unwilling to complete the informed consent form and the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- VIOME Precision Nutrition Program
- Keywords
- Viome, Diabetes Type 2, Diabetes, Pre-diabetes, VPNP, Nutrition, Supplements, Precision
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIOME Precision Nutrition ProgramBehavioural
Also called VPNP
Precision diet and supplement recommendations based on participants' microbiome results.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: VIOME Precision Nutrition Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ~3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start21 May 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants all received diet and supplement recommendations based on their microbiome results.
- Masking
- None (open label)
- Enrolment
- 2,912 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viome
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guruduth Banavar, PhD, Principal investigator, Viome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905485
- Sponsor's protocol ID
- V136 (VIOME-001 v5.0)
- Status last verified
- Jun 2021
- First submitted
- 24 May 2021
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Model to Better Predict Diabetes and/or Risk of Developing Diabetes
- ClinicalTrials.gov ID
- NCT04905485
- Acronym / sponsor ID
- V136 (VIOME-001 v5.0)
- Conditions
- Diabetes Type 2, Diabetes, Pre-diabetes
- Keywords
- Viome, Diabetes Type 2, Diabetes, Pre-diabetes, VPNP, Nutrition, Supplements, Precision
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,912 participants (actual)
- Lead sponsor
- ViomeIndustry (pharma, biotech, devices)
- Study start
- 21 May 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants all received diet and supplement recommendations based on their microbiome results.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Behavioral: VIOME Precision Nutrition ProgramAll participants received the intervention in this trial. They received recommendations on their diets and supplements based on their results of microbiome expression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Viome customer
- GI test collected at home using Viome test kit
- US citizen
- 18+ years old
- Is not participating in any other Viome study
Key exclusion criteria (1 listed)
- Unable/unwilling to complete the informed consent form and the questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIOME Precision Nutrition ProgramAlso: VPNPPrecision diet and supplement recommendations based on participants' microbiome results. | Behavioural | Intervention |
Primary outcome
Difference in VIOME's Type 2 diabetes risk score
Time frame: ~3 months
"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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guruduth Banavar, PhD principal investigator
Viome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIOME Precision Nutrition Program in people with Diabetes Type 2 and Diabetes, run by Viome at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in VIOME's Type 2 diabetes risk score (time frame: ~3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.