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

Trial ID or NCT#



not recruiting iconNOT RECRUITING


The objective of this study is to compare two metabolically distinct diets, WFKD vs Med-Plus, in order to examine the potential benefits, and unintended consequences, of going beyond a focus on maximally avoiding added sugars and refined grains, to also avoiding legumes, fruits, and whole grains.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. - Age ≥18 - Diagnosed with type 2 diabetes mellitus, OR prediabetes (defined as HbA1c 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:
  1. - 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


Justin L. Sonnenburg
Christopher Gardner
Sun Kim, M.D. M.S.
Sun Kim, M.D. M.S.
Associate Professor of Medicine (Endocrinology)

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Jennifer Robinson, PhD