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

The proposed randomized clinical trial will investigate differential population-specific effects of two low-carbohydrate (low-carb) diet patterns, addressing a gap in the evidence base in this area that will lead to 1) improved treatment strategies for common adverse clinical conditions, 2) improved health for these individuals, and 3) long-term decreases in health care costs. This impactful research will advance the field of personalized and precision medicine.

Inclusion criteria

• Age ≥18
• Diagnosed with type 2 diabetes mellitus, OR prediabetes (defined as HbA1c </= 5.7% OR 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