Status:
RECRUITING
Ketogenic Diet and Diabetes Demonstration Project
Lead Sponsor:
University of New Mexico
Conditions:
Type 2 Diabetes
PreDiabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
KDDP is a prospective, 12-month pilot study comparing the effects of a novel lifestyle program, the Ketogenic Diet and Diabetes Demonstration Project (KDDP) to those of the National Diabetes Preventio...
Detailed Description
KDDP is a prospective, 12-month pilot study comparing the effects of the KDDP vs. CDC NDPP in patients with obesity and dysglycemia. KDDP is the Ketogenic Diet and Diabetes Demonstration Project arm. ...
Eligibility Criteria
Inclusion
- Men and women ≥ 18 years old
- BMI ≥27 kg/m2
- Hemoglobin A1c ≥ 5.7% and/or fasting plasma glucose of 100-125 mg/dL
Exclusion
- Known clinical cardiovascular disease (i.e. prior stroke, myocardial infarction, peripheral artery disease)
- LDL cholesterol ≥ 190 mg/dL
- Triglycerides ≥ 500 mg/dL
- History of type 1 diabetes
- History of diabetic ketoacidosis
- Individuals requiring insulin
- Advanced renal disease
- Advanced liver disease
- Terminal cancer
- Pregnancy
Key Trial Info
Start Date :
September 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06115265
Start Date
September 5 2023
End Date
October 1 2026
Last Update
June 25 2025
Active Locations (1)
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1
University of New Mexico
Albuquerque, New Mexico, United States, 87131