NCT06115265Recruiting
Ketogenic Diet and Diabetes Demonstration Project
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 17 Oct 2023
- Start date
- 5 Sept 2023
- Primary completion date
- 30 Oct 2026
- Lead sponsor
- University of New Mexico
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT06115265
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 5 Sept 2023 to the primary completion date, 30 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known clinical cardiovascular disease (i.e. prior stroke, myocardial infarction, peripheral artery disease)
Other illness
- History of type 1 diabetes
- History of diabetic ketoacidosis
- Advanced renal disease
- Advanced liver disease
- Terminal cancer
Lab values
- LDL cholesterol ≥ 190 mg/dL
- Triglycerides ≥ 500 mg/dL
Other
- Individuals requiring insulin
- Pregnancy
Who the study is looking for
- Men and women ≥ 18 years old
- BMI ≥27 kg/m2
- Hemoglobin A1c ≥ 5.7% and/or fasting plasma glucose of 100-125 mg/dL
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of New Mexico Coordinator of this site? Confirm its status | Albuquerque | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.