Comparing ketogenic and low-fat diets for diabetes management
Ketogenic Diet and Diabetes Demonstration Project
This study tests whether a ketogenic diet or a low-fat diet works better for managing blood sugar and overall health in people with type 2 diabetes or prediabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of New Mexico Academic / other |
| Locations | 1 site (Albuquerque, New Mexico) |
| Trial ID | NCT06115265 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a BMI of 27 kg/m2 or higher and elevated hemoglobin A1c or fasting plasma glucose levels.
Not a fit: Patients with known cardiovascular disease, advanced renal or liver disease, or those requiring insulin will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective dietary intervention for managing type 2 diabetes and prediabetes.
How similar studies have performed: Previous studies have shown promising results for ketogenic diets in managing diabetes, suggesting that this approach may be effective, though the specific comparison to the NDPP is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Albuquerque, New Mexico
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.