MedTrace Logo

Ketogenic Diet and Diabetes Demonstration Project

NCT06115265 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-06-25

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • University of New Mexico

    lead OTHER

Principal Investigators

  • Kristen Gonzales, MD · University of New Mexico

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-05
Primary Completion
2026-05-30
Completion
2026-10-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06115265 on ClinicalTrials.gov