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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.

Plain-language title generated from the registry record
Registry title: Ketogenic Diet and Diabetes Demonstration Project

Key facts

Where
Albuquerque, United StatesSee the site

Where in United States

  • University of New MexicoAlbuquerque, United StatesTaking people

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Trial details

Who runs it
University of New Mexico
Trial code
NCT06115265
Record updated
3 September 2026
Original description
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.Read full original descriptionShow less

Ketogenic Diet and Diabetes Demonstration Project

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.

Inclusion: 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: 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.

ClinicalTrials.gov NCT06115265