Actively Recruiting
Ketogenic Diet and Diabetes Demonstration Project Comparing Ketogenic and Low Fat Diets in Type 2 Diabetes and Prediabetes
Led by University of New Mexico · Updated on 2025-06-25
40
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of two lifestyle programs on people with type 2 diabetes or prediabetes who also have obesity and blood sugar problems. This 12-month pilot study compares a medically supervised ketogenic diet program called Ketogenic Diet and Diabetes Demonstration Project (KDDP) with the National Diabetes Prevention Program (NDPP) that uses a low fat diet. The goal is to see how these diets affect blood sugar control, cholesterol, blood pressure, heart rate, weight, and coronary artery calcium scores. Participants in the KDDP group will follow a ketogenic diet with less than 20 grams of carbohydrates per day, attend weekly educational sessions, and perform home ketone breath tests to ensure they maintain ketosis. Both KDDP and NDPP groups receive the same comprehensive lifestyle counseling and follow up from trained dieticians, with the main difference being the diet type. The NDPP group will follow a low fat diet. Both groups will be matched by age, sex, weight, and A1c levels. During the study, participants will have their weight, height, blood pressure, heart rate, hemoglobin A1c, fasting glucose, and cholesterol levels measured at the start and every 3 months up to 12 months. Coronary artery calcium scans will be done at the beginning and end of the study to evaluate heart artery health. Researchers will track these health markers to compare how the two diets affect metabolic health over time.
CONDITIONS
Brief Title
Ketogenic Diet and Diabetes Demonstration Project
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 years or older
- Body mass index (BMI) of 27 kg/m2 or higher
- Hemoglobin A1c of 5.7% or higher and/or fasting plasma glucose between 100 and 125 mg/dL
You will not qualify if you...
- Known clinical cardiovascular disease such as prior stroke, heart attack, or peripheral artery disease
- LDL cholesterol of 190 mg/dL or higher
- Triglycerides of 500 mg/dL or higher
- History of type 1 diabetes
- History of diabetic ketoacidosis
- Individuals requiring insulin
- Advanced kidney disease
- Advanced liver disease
- Terminal cancer
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants follow either a ketogenic diet or a low fat diet and attend weekly educational sessions with dieticians as part of a comprehensive lifestyle intervention program.
Weekly visits for up to 12 months
Duration - 12 months
Throughout the study, participants have baseline and follow-up measurements including weight, blood pressure, heart rate, blood markers, and CAC scanning at baseline and 12 months.
Visits every 3 months and at study completion
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
M
Matthew Bouchonville, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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