Ketogenic Diet and Diabetes Demonstration Project for Type 2 Diabetes, PreDiabetes, and Obesity

This study is looking at how a ketogenic diet compares to a low-fat diet for people with Type 2 Diabetes, PreDiabetes, or Obesity. You would be assigned to either a medically-supervised ketogenic diet or a low-fat diet, both with comprehensive lifestyle counseling. The researchers want to see how these diets affect your weight, blood sugar (glycemic control), and cholesterol levels. To join, you need to be at least 18 years old, have a BMI of 27 or higher, and have elevated A1c or fasting blood sugar. The study aims to enroll 40 participants, but its current status is unclear.

Study design
This is an interventional study comparing two different diet plans. It plans to enroll 40 participants.
What's involved
You would attend weekly educational sessions with dieticians for 12 months. You would also have regular measurements taken, including weight, blood pressure, and blood tests.
Compensation
Not stated in the trial record.
Follow-up
Your weight will be measured at 12 months after starting the study.

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NCT06115265

Ketogenic Diet and Diabetes Demonstration Project

Recruiting
NAAges 18+InterventionalTreatment
University of New Mexico
~40 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:Ketogenic dietLow Fat diet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Weight in kg
Measured over 12 months
Type 2 Diabetes
PreDiabetes
Obesity
Ketogenic Dieting
1 sites across 1 states
New Mexico1
  • Kristen Gonzales, MD · PRINCIPAL_INVESTIGATOR · University of New Mexico

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Eligibility criteria

Inclusion

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

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
  • Weight in kg12 months

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