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Ketogenic Diet and Diabetes Demonstration Project
Who can join
Ages 18 and older · All sexes · Healthy volunteers welcome
Full eligibility criteria
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
About the study
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.
What is being tested
- Ketogenic diet (behavioral)
- Low Fat diet (behavioral)
Sponsor: University of New Mexico · Participants: 40 · Started: Sep 5, 2023
Contact the study team
- Kristen M Gonzales, MD · Phone: 505-272-3840
- Matthew Bouchonville, MD · Phone: 505-272-3840
Official record on ClinicalTrials.gov — NCT06115265
Locations in the U.S.
| New Mexico | University of New Mexico, Albuquerque |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.