RECRUITING

Ketogenic Diet and Diabetes Demonstration Project

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Ketogenic Diet and Diabetes Demonstration Project

Quick Facts

Study Start:2023-09-05
Study Completion:2025-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06115265

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women ≥ 18 years old
  2. * BMI ≥27 kg/m2
  3. * Hemoglobin A1c ≥ 5.7% and/or fasting plasma glucose of 100-125 mg/dL
  1. * Known clinical cardiovascular disease (i.e. prior stroke, myocardial infarction, peripheral artery disease)
  2. * LDL cholesterol ≥ 190 mg/dL
  3. * Triglycerides ≥ 500 mg/dL
  4. * History of type 1 diabetes
  5. * History of diabetic ketoacidosis
  6. * Individuals requiring insulin
  7. * Advanced renal disease
  8. * Advanced liver disease
  9. * Terminal cancer
  10. * Pregnancy

Contacts and Locations

Study Contact

Kristen M Gonzales, MD
CONTACT
505-272-3840
KrGonzales@salud.unm.edu
Matthew Bouchonville, MD
CONTACT
505-272-3840
mbouchonville@salud.unm.edu

Principal Investigator

Kristen Gonzales, MD
PRINCIPAL_INVESTIGATOR
University of New Mexico

Study Locations (Sites)

University of New Mexico
Albuquerque, New Mexico, 87131
United States

Collaborators and Investigators

Sponsor: University of New Mexico

  • Kristen Gonzales, MD, PRINCIPAL_INVESTIGATOR, University of New Mexico

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-05
Study Completion Date2025-10-01

Study Record Updates

Study Start Date2023-09-05
Study Completion Date2025-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • Type 2 Diabetes
  • PreDiabetes
  • Obesity
  • Ketogenic Dieting