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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| onsite | Experimental | 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. |
|
| web-based | Experimental | 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. |
|
| Control (usual care) | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virta Program | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Type-2 Diabetes Status | Type-2 diabetes status will be evaluated by measuring Hemoglobin A1c (HbA1c) | 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:
| 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 | 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 and 24 Months |
| Change from Baseline Serum Lipids |
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Inclusion Criteria:
Body weight/Diabetes:
Body weight/ Pre-diabetes:
• Diagnosis of metabolic syndrome with BMI >30 and HbA1c > 5.6 (note: this does not apply to usual care control subjects)
Ethnicity: all ethnic groups
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Hallberg, DO, MS | Indiana University Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Health Arnett Medical Weight Loss | West Lafayette | Indiana | 47904 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24152742 | Background | Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity among adults: United States, 2011-2012. NCHS Data Brief. 2013 Oct;(131):1-8. | |
| 20071471 | Background | Flegal KM, Carroll MD, Ogden CL, Curtin LR. Prevalence and trends in obesity among US adults, 1999-2008. JAMA. 2010 Jan 20;303(3):235-41. doi: 10.1001/jama.2009.2014. Epub 2010 Jan 13. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D018149 | Glucose Intolerance |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Serum lipids including lipoprotein size and number
| 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 | 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) | 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:
| 42 and 60 Months (intervention arms only) |
| Change from Baseline Body Weight | Body weight will be evaluated on a calibrated scale | 42 and 60 Months (intervention arms only) |
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| D004700 | Endocrine System Diseases |
| D006943 | Hyperglycemia |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |