Status:
COMPLETED
Contrasting Ketogenic and Mediterranean Diets in Individuals With Type 2 Diabetes and Prediabetes: The Keto-Med Trial
Lead Sponsor:
Stanford University
Conditions:
Diabetes Mellitus, Type 2
PreDiabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 maxima...
Detailed Description
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2020
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT03810378
Start Date
June 5 2019
End Date
December 6 2020
Last Update
February 21 2023
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94305