Contrasting Ketogenic and Mediterranean Diets in Individuals With Type 2 Diabetes and Prediabetes: The Keto-Med Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Endocrine, Diabetes, Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/3/2019 |
| Start Date: | March 21, 2019 |
| End Date: | March 2020 |
| Contact: | Jennifer Robinson, PhD |
| Email: | jlmorris@stanford.edu |
| Phone: | 650-736-8577 |
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.
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.
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.
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, on oral anti-T2DM medications only (stable
dose for 3 months)
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
- 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
We found this trial at
1
site
450 Serra Mall
Stanford, California 94305
Stanford, California 94305
(650) 723-2300
Principal Investigator: Christopher D Gardner, PhD
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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