Comparing ketogenic and low-fat diets for diabetes management

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Ketogenic Diet and Diabetes Demonstration Project (KDDP) is a 12-month pilot study designed to compare the metabolic effects of a medically-supervised ketogenic diet against a low-fat diet as part of the National Diabetes Prevention Program (NDPP). Participants in the KDDP arm will receive education on maintaining a ketogenic diet with less than 20g of carbohydrates per day, while those in the NDPP arm will follow a low-fat diet. Both groups will undergo regular monitoring of various health parameters, including glycemic control and lipid levels, to assess the effectiveness of each dietary approach. The study aims to provide insights into how these diets impact individuals with type 2 diabetes or prediabetes.

Why it matters

Who can join: the full rules

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

Where it's running

• University of New Mexico
  Albuquerque, New Mexico, United States Recruiting

Study contacts

• Principal investigator: Kristen Gonzales, MD — University of New Mexico
• Study coordinator: Kristen M Gonzales, MD
• Email: KrGonzales@salud.unm.edu
• Phone: 505-272-3840

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.