Diabetes Mellitus, Type 2, Metabolic Syndrome, Pre-diabetes
Conditions
Brief summary
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
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.
Interventions
OTHERVirta Program
Sponsors
Virta Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1. 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 2. single arm, before-and-after study of patients with prediabetes who self-select to receive the intervention (no comparison group)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Type-2 Diabetes Status | 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms) | Type-2 diabetes status will be evaluated by measuring Hemoglobin A1c (HbA1c) |
| Change from Baseline Metabolic Syndrome Status | 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms) | 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 |
| Change from Baseline Body Weight | 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms) | Body weight will be evaluated on a calibrated scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Type-2 Diabetes Status | 42 and 60 Months (intervention arms only) | Type-2 diabetes status will be evaluated by measuring Hemoglobin A1c (HbA1c) |
| Change from Baseline Carotid Intima Media Thickness (CIMT) (intervention and usual care arms, participants with type 2 diabetes only) | 12 and 24 Months | Ultrasound Measurement of the Carotid Artery |
| Change from Baseline Body Weight | 42 and 60 Months (intervention arms only) | Body weight will be evaluated on a calibrated scale |
| Change from Baseline Metabolic Syndrome Status | 42 and 60 Months (intervention arms only) | 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 |
| Change from Baseline Serum Lipids | 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms) | Serum lipids including lipoprotein size and number |
| Change from Baseline Body Composition | 3,12 and 24 Months (intervention arms only) | 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 |
Countries
United States
Outcome results
None listed