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

Exclusion Criteria

• •Weight \< 110 lb
• •BMI \> 40
• •LDL-C \>190 mg/dL
• •Blood pressure: SBP \> 160 mmHg OR DBP: \> 90 mmHg
• •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