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Not Recruiting
Trial ID: NCT03810378
Contrasting Ketogenic and Mediterranean Diets in Individuals With Type 2 Diabetes and Prediabetes: The Keto-Med Trial
Associate Professor of Medicine (Endocrinology)
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
behavioral: Mediterranean Diet (Med-Plus)
behavioral: Well-Formulated Ketogenic Diet (WFKD)
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jennifer Robinson, PhD
650-736-8577