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Ketogenic Diet and Diabetes Demonstration Project

University of New Mexico · NCT06115265

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
40
US sites recruiting
1
Study start
September 5, 2023
Record last updated
September 3, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Ketogenic diet; Low Fat diet

Conditions: Type 2 Diabetes; PreDiabetes; Obesity; Ketogenic Dieting

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • University of New Mexico

    Albuquerque, NM 87131

    Site contact: Kristen Gonzales, MD · 505-272-3840 · KrGonzales@salud.unm.edu

Study contacts (from the official record)

  • Kristen M Gonzales, MD · 505-272-3840 · KrGonzales@salud.unm.edu
  • Matthew Bouchonville, MD · 505-272-3840 · mbouchonville@salud.unm.edu
All weight loss studies in New Mexico →
Ketogenic Diet and Diabetes Demonstration Project (NCT06115265) | Bored Studies