Dietary Intervention in Type-2 Diabetes and Pre-Diabetes

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.

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