Recruiting

Ketogenic Diet

Sponsor:

University of New Mexico

Code:

NCT06115265

Conditions

Type 2 Diabetes

PreDiabetes

Obesity

Ketogenic Dieting

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Ketogenic diet

Low Fat diet

Study Details

Brief summary:

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.

Conditions

Type 2 Diabetes

PreDiabetes

Obesity

Ketogenic Dieting

Study ID

NCT06115265

Start date

Sep 5, 2023

Status verified date

Jun, 2026

Completion date

Oct 30, 2026

Anticipated

Primary completion date

Oct 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: KDDP

KDDP - Participants enrolled in the KDDP arm will be placed on a traditional ketogenic diet (<20 grams of carbohydrate/day).

experimental: NDPP

NDPP - Participants enrolled in the NDPP arm will be placed on a low fat diet.

Interventions

Ketogenic diet

KDDP and NDPP will deliver identical comprehensive lifestyle counseling and follow up to participants, but dietary interventions in each group will differ, with KDDP participants receiving a ketogenic diet and NDPP participants receiving a low fat diet.

Low Fat diet

KDDP and NDPP will deliver identical comprehensive lifestyle counseling and follow up to participants, but dietary interventions in each group will differ, with KDDP participants receiving a ketogenic diet and NDPP participants receiving a low fat diet.

Primary outcome measure

  • Weight in kg [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Kristen M Gonzales, MD

505-272-3840KrGonzales@salud.unm.edu

Matthew Bouchonville, MD

505-272-3840mbouchonville@salud.unm.edu

Locations

University of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87131

Contacts

Kristen Gonzales, MD

505-272-3840KrGonzales@salud.unm.edu

Matthew Bouchonville, MD

5052723840mbouchonville@salud.unm.edu

More Information

Sponsor

University of New Mexico

Last update posted

Sep 3, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of New Mexico on 2026-09-03.