Ketogenic Diet and Diabetes Demonstration Project

Recruiting now · Not applicable

Conditions studied: Type 2 Diabetes, PreDiabetes, Obesity, Ketogenic Dieting

In brief

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.

Key facts

Study ID

NCT06115265

Run by

University of New Mexico

People needed

40

Starts

2023-09-05

Expected to finish

2026-10-01

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men and women ≥ 18 years old
• BMI ≥27 kg/m2
• Hemoglobin A1c ≥ 5.7% and/or fasting plasma glucose of 100-125 mg/dL

You may not qualify if…

• 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

• University of New Mexico — Albuquerque, New Mexico, United States (enrolling)

Full record on ClinicalTrials.gov

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