Clinical trial

Ketogenic Diet and Diabetes Demonstration Project

Recruiting now · Not applicable · 1 countries · Registry ID NCT06115265

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersAccepted

ConditionType 2 Diabetes, PreDiabetes, Obesity, Ketogenic Dieting

Full registry 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

Treatments and study arms

Ketogenic diet

Behavioral

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.

Low Fat diet

Behavioral

Primary outcomes

Weight in kg12 months

Change in weight over 12-months in KDDP arm vs NDPP arm

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of New Mexico🇺🇸 Albuquerque, New Mexico, United States

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Kristen Gonzales, MDContact

Email · Call 505-272-3840

Matthew Bouchonville, MDContact

Email · Call 5052723840