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Nutritional Ketosis
Virtual Lifestyle Intervention for Type 2 Diabetes (VICTOR Trial)
N/A
Waitlist Available
Led By Cecilia Low Wang, MD
Research Sponsored by Colorado Prevention Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up group 1: baseline, 3.5 months and 7 months / group 2: 3.5 months and 7 months
Awards & highlights
VICTOR Trial Summary
This trialwill evaluate whether individuals in rural communities accept a virtual lifestyle intervention to improve glucose control in those with type 2 diabetes.
Who is the study for?
The VICTOR-Pilot study is for adults aged 18-79 with type 2 diabetes who are overweight, have an HbA1c level over 7.5%, and take medication for diabetes. Participants should be able to engage in virtual care and give electronic consent. Those with severe health conditions, recent serious diabetic complications, or women who are pregnant/planning pregnancy within nine months cannot join.Check my eligibility
What is being tested?
This trial tests the Virta Health program's acceptability and effectiveness in rural Colorado communities. The program uses a virtual lifestyle intervention that induces nutritional ketosis to control blood sugar levels in people with type 2 diabetes.See study design
What are the potential side effects?
While specific side effects aren't listed here, interventions like Virta Health that induce nutritional ketosis may cause symptoms such as fatigue, headache, dizziness or digestive issues during the initial adjustment period.
VICTOR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ group 1: baseline, 3.5 months and 7 months / group 2: 3.5 months and 7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~group 1: baseline, 3.5 months and 7 months / group 2: 3.5 months and 7 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in hemoglobin A1c (Percent)
Secondary outcome measures
Change in BMI
Change in hemoglobin A1c
Change in number and/or doses of anti-hyperglycemic medications • doses of anti-hyperglycemic medications
Other outcome measures
Acceptability of referral
Acceptability of referral over time
Acceptance of referral to continuous remote care
+8 moreVICTOR Trial Design
2Treatment groups
Active Control
Group I: Nutritional Ketosis Intervention ReferralActive Control1 Intervention
The comprehensive remotely-delivered continuous remote care to induce nutritional ketosis combined with remote medication management is the Virta treatment, and while on this treatment, subjects will have access to Virta health coaches and licensed medical providers who will perform medical therapy management, health coaching, nutrition and behavior change education, biometric feedback, and the option to participate in a community for peer support.
Group II: CHHS Standard Care - Delayed Referral to Nutritional Ketosis InterventionActive Control1 Intervention
All subjects will be enrolled in Colorado Heart Healthy Solutions (CHHS), which consists of community health worker (CHW) contact and sessions on: 1) cardiovascular disease knowledge; 2) Health behavior change through skill building to improve diet (e.g., portion sizes, increasing fruit/vegetable intake, reducing intake of sugar sweetened beverages, decreasing fast food meals, etc.), increase physical activity, and improve well-being, tailored to individual subjects' risk profile and self-identified goals; and 3) Connection to services including primary care, mental health services if needed, and relevant community programs to address barriers (e.g. food insecurity, need for legal help) or to promote behavior change (e.g. free/low cost exercise programs).
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Who is running the clinical trial?
Colorado Prevention CenterLead Sponsor
12 Previous Clinical Trials
22,574 Total Patients Enrolled
Virta HealthIndustry Sponsor
4 Previous Clinical Trials
50,945 Total Patients Enrolled
Cecilia Low Wang, MDPrincipal InvestigatorCPC Clinical Research
1 Previous Clinical Trials
16 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many volunteers have signed up for this clinical experiment?
"Confirmed; clinicaltrials.gov depicts that this medical investigation initially posted on March 2nd 2021 is currently looking for volunteers. 60 participants are required from 3 separate research centres with the most recent update published on November 9th 2022."
Answered by AI
To what extent do certain individuals have a greater aptitude for participating in this study?
"60 participants suffering from diabetes mellitus type 2, aged 18 to 79, with a BMI of 25 kg/m2 or higher and who are capable of engaging in virtual care will be admitted for the trial."
Answered by AI
Are there any openings remaining for this research endeavor?
"Affirmative. Clinicaltrials.gov documents that this clinical trial, first posted on March 2nd 2021, is currently recruiting participants. The study seeks to enrol 60 individuals from 3 distinct facilities."
Answered by AI
Does this trial necessitate participants to be of legal age?
"This medical trial is open to patients aged 18-79. 46 studies have been conducted for individuals younger than 18, and 677 trials are specified for those over the age of 65."
Answered by AI
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