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RECRUITINGINTERVENTIONAL

Ketogenic Diet and Diabetes Demonstration Project

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - Men and women ≥ 18 years old - BMI ≥27 kg/m2 - Hemoglobin A1c ≥ 5.7% and/or fasting plasma glucose of 100-125 mg/dL Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BEHAVIORAL

Ketogenic diet

KDDP and NDPP will deliver identical comprehensive lifestyle counseling and follow up to participants, but dietary interventions in each group will differ, with KDDP participants receiving a ketogenic diet and NDPP participants receiving a low fat diet.

BEHAVIORAL

Low Fat diet

KDDP and NDPP will deliver identical comprehensive lifestyle counseling and follow up to participants, but dietary interventions in each group will differ, with KDDP participants receiving a ketogenic diet and NDPP participants receiving a low fat diet.

Locations (1)

University of New Mexico
Albuquerque, New Mexico, United States