Ketogenic Diet and Diabetes Demonstration Project (KDDP)

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; PreDiabetes; Type 2 Diabetes; Ketogenic Dieting
• Intervention / Treatment: Behavioral: Ketogenic diet; Behavioral: Low Fat diet

Detailed Description

KDDP is a prospective, 12-month pilot study comparing the effects of the KDDP vs. CDC NDPP in patients with obesity and dysglycemia. KDDP is the Ketogenic Diet and Diabetes Demonstration Project arm. Individuals enrolled in the KDDP arm will attend a mandatory Weight Management class through the Center for Diabetes and Nutrition Education, and they will participate in a standard comprehensive lifestyle intervention program that is identical to that of the NDPP with the exception of dietary recommendations. Individuals in the KDDP arm will be educated on and follow a ketogenic diet (<20g carbohydrates/day). They will receive guidance on tracking carbohydrate intake daily, and home point-of-care ketone breath testing will be performed at regular intervals to ensure that ketosis is being achieved and maintained. They will attend weekly educational sessions facilitated by trained dieticians. Individuals enrolled in the CDC NDPP arm will adhere to a low fat diet and receive identical follow up with the dieticians relative to those enrolled in the KDDP arm. Individuals in both arms will be matched for age, sex, weight, and A1c.

Baseline measures at study entry will include weight, height, systolic and diastolic blood pressure, heart rate, hemoglobin A1c, fasting plasma glucose, total cholesterol, triglycerides, HDL cholesterol, and LDL cholesterol. These parameters will be measured every 3 months throughout the study and at study completion. Additionally, participants in both groups will be consented to undergo CAC scanning at baseline and at 12 months to assess for any differences in dietary interventions on CAC scores.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristen M Gonzales, MD; Phone Number: 505-272-3840; Email: KrGonzales@salud.unm.edu
• Study Contact Backup: Name: Matthew Bouchonville, MD; Phone Number: 505-272-3840; Email: mbouchonville@salud.unm.edu

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • Recruiting
      • University of New Mexico
      • Contact: Matthew Bouchonville, MD; Phone Number: 5052723840; Email: mbouchonville@salud.unm.edu
      • Contact: Kristen Gonzales, MD; Phone Number: 5052723840; Email: KrGonzales@salud.unm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KDDP; KDDP - Participants enrolled in the KDDP arm will be placed on a traditional ketogenic diet (<20 grams of carbohydrate/day).	Behavioral: 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.
Experimental: NDPP; NDPP - Participants enrolled in the NDPP arm will be placed on a low fat diet.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight in kg	Change in weight over 12-months in KDDP arm vs NDPP arm	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure in mmHg	Changes in the above measures from baseline to 12 months in KDDP arm vs. NDPP arm	12 months
Heart rate in beats per minute (BPM)	Changes in heart rate from baseline to 12 months in KDDP arm vs. NDPP arm	12 months
HbA1c as a percent	Changes in HbA1c from baseline to 12 months in KDDP arm vs. NDPP arm	12 months
Fasting lipids in mg/dL	Changes in fasting lipids from baseline to 12 months in KDDP arm vs. NDPP arm	12 months
Fasting plasma glucose in mg/dL	Changes in fasting plasma glucose from baseline to 12 months in KDDP arm vs. NDPP arm	12 months
CAC scores	Changes in CAC scores from baseline to 12 months in KDDP arm vs. NDPP arm	12 months

Collaborators and Investigators

• Sponsor: University of New Mexico
• Investigators: Principal Investigator: Kristen Gonzales, MD, University of New Mexico

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2023
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 30, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus
• Other Study ID Numbers: 22-364

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual data will not be shared with researchers outside of those directly conducting this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No