ClinConnect ClinConnect Logo
Search / Trial NCT06115265

Ketogenic Diet and Diabetes Demonstration Project

Launched by UNIVERSITY OF NEW MEXICO · Oct 30, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

The Ketogenic Diet and Diabetes Demonstration Project (KDDP) is a research study that aims to understand how a specific diet—called the ketogenic diet—can help people with type 2 diabetes, prediabetes, and obesity. This study will last for 12 months and will compare the effects of the ketogenic diet to a traditional low-fat diet used in the National Diabetes Prevention Program (NDPP). Researchers want to see how these diets affect various health measures, like blood sugar levels, cholesterol, blood pressure, heart rate, weight, and heart health.

To be eligible for this study, participants must be at least 18 years old, have a body mass index (BMI) of 27 or higher, and have specific blood sugar levels indicating prediabetes or diabetes. However, people with certain health conditions, such as heart disease or advanced liver or kidney disease, cannot take part in the study. Participants can expect to follow a medically-supervised ketogenic diet while receiving support and guidance over the course of the year. This study is currently recruiting participants, and it’s an exciting opportunity for those looking to manage their diabetes and improve their health through dietary changes.

Gender

ALL

Eligibility 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

About University Of New Mexico

The University of New Mexico (UNM) is a leading academic institution dedicated to advancing healthcare through innovative research and clinical trials. With a robust commitment to improving patient outcomes, UNM leverages its interdisciplinary expertise and state-of-the-art facilities to conduct cutting-edge clinical research across various fields. The university fosters collaboration among researchers, clinicians, and community partners, ensuring that its trials are not only scientifically rigorous but also responsive to the needs of diverse populations. UNM is dedicated to translating research findings into practical applications, ultimately contributing to the enhancement of medical knowledge and the quality of care.

Locations

Albuquerque, New Mexico, United States

Patients applied

0 patients applied

Trial Officials

Kristen Gonzales, MD

Principal Investigator

University of New Mexico

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported