Contrasting Ketogenic and Mediterranean Diets in Individuals With Type 2 Diabetes and Prediabetes: The Keto-Med Trial

Inclusion Criteria:

   - Age ≥18

   - Diagnosed with type 2 diabetes mellitus, OR prediabetes (defined as HbA1c    Fasting Glucose of >100 mg/dL)

Identify exclusion criteria.

   - Weight < 110 lb

   - BMI > 40

   - LDL-C >190 mg/dL

   - Blood pressure: SBP > 160 mmHg OR DBP: > 90 mmHg

Exclusion Criteria:

   - Weight < 110 lb

   - BMI ≥ 40

   - LDL-C >190 mg/dL

   - Systolic blood pressure (SBP) > 160 mmHg OR Diastolic blood pressure (DBP) > 90 mmHg

   - Diagnosed with type 1 diabetes or history of ketoacidosis

   - Uncontrolled and untreated diabetes (by discretion of study physician)

   - Active cardiovascular disease (in past year with myocardial infarction, coronary stent
   or bypass surgery)

   - Kidney disease (eGFR less than 50 mL/min per 1.73 m2)

   - Liver disease (liver transaminase higher than 3 times the normal range for the
   laboratory)

   - Symptomatic gallstones

   - History of bariatric surgery

   - Anemia

   - Taking any of the following medications in past 3 months: SGLT-2 inhibitors, GLP-1
   receptor agonist, Insulin, Amylin analog, Alpha-glucosidase inhibitor, Dopamine
   agonist, Bile acid sequestrant.

   - Taking any medications for weight loss

   - History of active cancer in the past 3 years except for squamous or basal cell
   carcinomas of the skin that have been medically managed by local excision

   - Unstable dietary history as defined by major changes in diet during the previous
   month, where the subject has eliminated or significantly increased a major food group
   in the diet.

   - Recent history of chronic excessive alcohol consumption defined as more than five
   1.5-ounce servings of 80 proof distilled spirits, five 12-ounce servings of beer or
   five 5-ounce servings of wine per day; or > 14 drinks/week.

   - Women: Pregnant currently or planning to become pregnant during the course of the
   study, and/or breastfeeding

   - Regular/frequent use of smoking or chewing tobacco, e-cigarettes, cigars or other
   nicotine-containing products

   - Regular use of prescription opiate pain medication