Dietary Intervention in Type-2 Diabetes and Pre-Diabetes

Virta Health

Status: Completed

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

Treatments: Other: Virta Program

Study type: Interventional

Funder types: Industry

Identifiers

NCT02519309

2015-1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 465 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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465 participants in 3 patient groups

onsite

Experimental group

Description:

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.

Treatment:

Other: Virta Program

web-based

Experimental group

Description:

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.

Treatment:

Other: Virta Program

Control (usual care)

No Intervention group

Description:

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.