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NCT04807218Completed

Virta Intervention in CommuniTies in cOloRado (VICTOR-Pilot)

Virta Intervention in CommuniTies in cOloRado (VICTOR-Pilot) Pilot Study to Improve Diabetes and Cardiovascular Risk in Rural Communities

Source: ClinicalTrials.gov · Last updated 11 Mar 2025

Brief summary (registry, in English)

The VICTOR study plans to include rural communities served by Colorado Heart Healthy Solutions (CHHS) program and find out whether participants will accept a referral to a comprehensive virtual lifestyle intervention, Virta Health. The Virta Health program induces nutritional ketosis to improve glucose control in individuals with type 2 diabetes. The study will inform the acceptability of the referral, the retention of participants in lifestyle intervention, and the durability of effects on glucose control after the lifestyle intervention has ended.

Status (registry)
Completed
Study type
Interventional
Enrollment
51 (actual)
First submitted
16 Mar 2021
Start date
2 Mar 2021
Primary completion date
30 Aug 2024
Lead sponsor
Colorado Prevention Center
NCT number
NCT04807218

What you commit to

  • Study type: Interventional
  • Participants enrolled: 51
  • From 2 Mar 2021 to the primary completion date, 30 Aug 2024
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Type 1 diabetes
  • Admission for diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS) within the last 12 months
  • Postural orthostatic tachycardia syndrome (POTS) and/or recurrent syncope
  • Any condition which in the opinion of the investigator would make the study unsuitable for the subject including investigator opinion regarding inability to comply with Virta instructions

Lab values

  • Active severe psychiatric or medical condition(s) such as advanced renal (end-stage renal disease or CKD stage 4 or 5; eGFR \<30 mL/min), cardiac (NYHA Class 4 heart failure), or hepatic dysfunction (Child-Pugh Class C)

Other

  • Pregnant or planning pregnancy within the next 9 months
  • Lactating
  • Life expectancy \<1 year

Who the study is looking for

  • Able to provide electronic informed consent
  • Age 18 - 79 years old
  • Type 2 diabetes mellitus diagnosis by self-report and/or medical history
  • Taking 1 or more antihyperglycemic medications
  • Current HbA1c \> 7.5%
  • Body mass index (BMI) 25 kg/m2 or greater
  • Capable of engaging in virtual care

Age in the registry: 18 years to 79 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Northwest Colorado Health - Community Health Center & Prevention Services Craig
Coordinator of this site? Confirm its status
CraigUnited StatesUnknown status
High Plains Community Health Center
Coordinator of this site? Confirm its status
LamarUnited StatesUnknown status
Chaffee County Public and Environmental Health
Coordinator of this site? Confirm its status
SalidaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.