Ketogenic Diet and Diabetes Demonstration Project
Recruiting · NCT06115265 · Interventional (participants receive a specific treatment) · Lead sponsor: University of New Mexico
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed across 1 US state.
- University of New Mexico - Albuquerque, New Mexico, United States