Dietary Intervention in Type-2 Diabetes and Pre-Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Dietary Intervention in Type-2 Diabetics and Pre-Diabetics Emphasizing Personalized Carbohydrate Intake

Conditions
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Diabetes Mellitus, Type 2, Pre-diabetes, Metabolic Syndrome

Intervention / Treatment
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* Other: Virta Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body weight/Diabetes: Diagnosis of type-2 diabetes with BMI > 25 (without end-organ failure) Fasting glucose >126 mg/dL or HbA1c >6.5 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: BMI <30 without diagnosis of Type-2 diabetes, metabolic syndrome Type 1 diabetes History of keto-acidosis History of MI, stroke, angina, coronary insufficiency within the last 6 months Diabetic retinopathy requiring treatment Creatinine > 2.0 Urinary albumin > 1 g/d Impaired hepatic function (Bilirubin >2, Albumin < 3.5) Cholelithiasis or biliary dysfunction Cancer requiring treatment in the past 5 years, with the exception of non-melanoma skin cancer Chronic infectious disease requiring ongoing treatment Other chronic diseases or condition likely to limit lifespan to <6 years Non-English speaking Unable or unwilling to participate in group sessions (e.g., plans to relocate within the next year) or conform to a carbohydrate restricted diet lifestyle (e.g., food intolerances, religious or personal restrictions) Weight loss of >10% in past 6 months Currently pregnant or nursing, or planning to become pregnant during the study Major psychiatric disorder (e.g., schizophrenia, bipolar disorder) currently uncontrolled Excessive alcohol intake (acute or chronic) defined as average consumption of 3 or more alcohol-containing beverages daily or consumption of more than 14 alcoholic beverages per week

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: open label, non-randomized, before-and-after study of patients with type 2 diabetes who self-select the intervention (with education delivered via onsite group classes or web-based, self-selected by participant) or usual care single arm, before-and-after study of patients with prediabetes who self-select to receive the intervention (no comparison group)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: onsite<br>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<br> <br> |
| Experimental: web-based<br>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<br> <br> |
| No Intervention: Control (usual care)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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: 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 | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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: 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 | 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) |