Ketogenic diet versus low-fat diet for type 2 diabetes or prediabetes
Compares a ketogenic diet with a low-fat diet in adults with diabetes or prediabetes.
Key facts
- Who runs it
- University of New Mexico
- Where
- Albuquerque, United StatesSee the site
- Trial code
- Registry title
- Ketogenic Diet and Diabetes Demonstration Project
- Status
- Recruiting
- People taking part
- 40 people, planned
- Started
- 5 Sept 2023
- Planned end
- 30 Oct 2026
- Type of study
- Interventional, 2 groups
- Treatments tested
- Ketogenic diet
- Low Fat diet
- Record updated
- 3 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with type 2 diabetes or prediabetes who are overweight. It compares a ketogenic diet program with a low fat diet program.
- Age
- 18 years or older
- Sex
- Men and women
- Disease stage
- Prediabetes or type 2 diabetes, shown by hemoglobin A1c of 5.7% (39 mmol/mol) or higher and/or fasting plasma glucose of 100-125 mg/dL (5.6–6.9 mmol/L). BMI must be 27 kg/m2 or higher.
- Biomarker or test result
- Hemoglobin A1c ≥ 5.7% (39 mmol/mol) and/or fasting plasma glucose of 100-125 mg/dL (5.6–6.9 mmol/L)
Main reasons for not taking part
- Known heart or blood vessel disease, such as prior stroke, heart attack or peripheral artery disease
- LDL cholesterol 190 mg/dL (4.9 mmol/L) or higher, or triglycerides 500 mg/dL (5.6 mmol/L) or higher
- History of type 1 diabetes or diabetic ketoacidosis
- Needing insulin
- Advanced kidney disease, advanced liver disease, terminal cancer or pregnancy
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- Men and women ≥ 18 years old
- BMI ≥27 kg/m2
- Hemoglobin A1c ≥ 5.7% and/or fasting plasma glucose of 100-125 mg/dL
Who cannot take part
- Known clinical cardiovascular disease (i.e. prior stroke, myocardial infarction, peripheral artery disease)
- History of type 1 diabetes
- History of diabetic ketoacidosis
- Advanced renal disease
- Advanced liver disease
- Terminal cancer
- LDL cholesterol ≥ 190 mg/dL
- Triglycerides ≥ 500 mg/dL
- Individuals requiring insulin
- Pregnancy
Where in United States
- University of New MexicoAlbuquerque, United StatesContact: Kristen Gonzales, MDTaking people
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- KDDPTreatment being tested
KDDP - Participants enrolled in the KDDP arm will be placed on a traditional ketogenic diet (\<20 grams of carbohydrate/day).
Treatment: Ketogenic diet
- NDPPTreatment being tested
NDPP - Participants enrolled in the NDPP arm will be placed on a low fat diet.
Treatment: Low Fat diet
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Ketogenic Diet and Diabetes Demonstration Project
- Plain-language title
- Ketogenic diet versus low-fat diet for type 2 diabetes or prediabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 3 September 2026