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

Trial ID or NCT#

NCT03810378

Status

not recruiting iconNOT RECRUITING

Purpose

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

Investigator(s)

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

Contact us to find out if this trial is right for you.

Contact

Jennifer Robinson, PhD
650-736-8577