RecruitingNot ApplicableNCT06115265

Ketogenic Diet and Diabetes Demonstration Project


Sponsor

University of New Mexico

Enrollment

40 participants

Start Date

Sep 5, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study explores whether a ketogenic (very low carbohydrate, high fat) diet can help people who have prediabetes or are at risk for type 2 diabetes. The goal is to demonstrate the real-world effectiveness of this dietary approach on blood sugar control. **You may be eligible if:** - You are 18 or older - Your BMI is 27 or higher (overweight or obese) - You have prediabetes (HbA1c of 5.7% or higher, or fasting glucose of 100–125 mg/dL) **You may NOT be eligible if:** - You have a history of cardiovascular disease (stroke, heart attack, or peripheral artery disease) - Your LDL cholesterol is 190 mg/dL or higher - Your triglycerides are 500 mg/dL or higher - You have type 1 diabetes - You have had diabetic ketoacidosis - You currently use insulin - You have advanced kidney or liver disease - You have terminal cancer - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALKetogenic 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.

BEHAVIORALLow 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

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NCT06115265


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