Actively Recruiting
Ketogenic Diet and Diabetes Demonstration Project
Led by University of New Mexico · Updated on 2025-06-25
40
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 Prevention Program (NDDP). KDDP is modeled to mimic the delivery platform of NDPP with the exception that participants in KDDP will be placed on a medically-supervised ketogenic diet, and participants in NDPP will be placed on a low fat diet. The purpose of this study is to compare the metabolic effects of the KDDP and the NDPP on glycemic control, lipid parameters, blood pressure, heart rate, weight, and coronary artery calcium scores in individuals with either type 2 diabetes or prediabetes.
CONDITIONS
Official Title
Ketogenic Diet and Diabetes Demonstration Project
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 18 years old or older
- Body mass index (BMI) of 27 kg/m2 or higher
- Hemoglobin A1c level of 5.7% or higher and/or fasting plasma glucose between 100 and 125 mg/dL
You will not qualify if you...
- History of clinical cardiovascular disease such as stroke, heart attack, or peripheral artery disease
- LDL cholesterol level of 190 mg/dL or higher
- Triglyceride level of 500 mg/dL or higher
- History of type 1 diabetes
- History of diabetic ketoacidosis
- Use of insulin treatment
- Advanced kidney disease
- Advanced liver disease
- Terminal cancer
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
Research Team
K
Kristen M Gonzales, MD
CONTACT
M
Matthew Bouchonville, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here