An interventional study of Virta Program in Diabetes Mellitus, Type 2, Pre-diabetes and Metabolic Syndrome, sponsored by Virta Health. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-04-27.
Sponsored by Virta Health · Not applicable, Interventional, and Treatment
The primary purpose of this research is to demonstrate the therapeutic effects of implementing a well-formulated low carbohydrate lifestyle program over 2 years in patients with type 2 diabetes, pre-diabetes, and metabolic syndrome.
The primary purpose of this research is to demonstrate the therapeutic effects of implementing a well-formulated low carbohydrate lifestyle program over 2 years. Positive therapeutic effects would be represented by improved glycemic control in patients with type 2 diabetes without use of additional glycemic control medications and failure to progress to type 2 diabetes in individuals with pre-diabetes and metabolic syndrome.
Secondary purposes of this research are to determine if therapeutic effects of the intervention differ between patients who self-select onsite vs. web-based education delivery, explore relationships between change in LDL cholesterol and carotid intima media thickness, and to evaluate the sustainability of health outcomes achieved and the economic impact of therapeutic effects over 5 years.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's enrollment of 465 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Virta Health is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Body weight/Diabetes:
Body weight/ Pre-diabetes:
Ethnicity: all ethnic groups
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Education (the virta program) for the onsite group will be delivered in person, with 26 classes over 12 months including group and individual sessions. Sessions will be scheduled weekly for the first 3 months, biweekly during months 4-6, and monthly thereafter. Each session will last approximately 90 minutes.
Other: Virta Program
Education (the virta program) for the web-based educational group will be the same content as the onsite group, but delivered via the web and completed at the participant's own pace.
Other: Virta Program
The study will make no intervention to this group. Participants in this group will be recent referrals to a local diabetes education program and care for their condition will continue to be managed by their own medical providers.
Change from Baseline Type-2 Diabetes Status
Type-2 diabetes status will be evaluated by measuring Hemoglobin A1c (HbA1c)
Time frame: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
Change from Baseline Metabolic Syndrome Status
Metabolic syndrome status will be evaluated by standard markers. Metabolic syndrome is defined as having at least three of the following: * Waist circumference: ≥40 inches (men) or ≥35 inches (women) * Fasting triglycerides: ≥150 mg/dL * HDL-C: \<40 mg/dL (men) or \<50 mg/dL (women) * Blood pressure: ≥130/85 mm Hg or use of hypertensive medication * Fasting glucose: ≥ 100 mg/dL or use of hyperglycemia medication
Time frame: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
Change from Baseline Body Weight
Body weight will be evaluated on a calibrated scale
Time frame: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
Change from Baseline Carotid Intima Media Thickness (CIMT) (intervention and usual care arms, participants with type 2 diabetes only)
Ultrasound Measurement of the Carotid Artery
Time frame: 12 and 24 Months
Change from Baseline Serum Lipids
Serum lipids including lipoprotein size and number
Time frame: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
Change from Baseline Body Composition
Body composition will be determined using dual-energy X-ray absorptiometry (DXA), which provides accurate information on total body and regional fat, lean body mass, and bone mass
Time frame: 3,12 and 24 Months (intervention arms only)
Change from Baseline Type-2 Diabetes Status
Type-2 diabetes status will be evaluated by measuring Hemoglobin A1c (HbA1c)
Time frame: 42 and 60 Months (intervention arms only)
Change from Baseline Metabolic Syndrome Status
Metabolic syndrome status will be evaluated by standard markers. Metabolic syndrome is defined as having at least three of the following: * Waist circumference: ≥40 inches (men) or ≥35 inches (women) * Fasting triglycerides: ≥150 mg/dL * HDL-C: \<40 mg/dL (men) or \<50 mg/dL (women) * Blood pressure: ≥130/85 mm Hg or use of hypertensive medication * Fasting glucose: ≥ 100 mg/dL or use of hyperglycemia medication
Time frame: 42 and 60 Months (intervention arms only)
Change from Baseline Body Weight
Body weight will be evaluated on a calibrated scale
Time frame: 42 and 60 Months (intervention arms only)
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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