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Ketogenic Diet and Diabetes Demonstration Project
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 Start (Actual) 5 September 2023
🗓️ Primary Completion (Estimated) 1 May 2025
✅ Study Completion (Estimated) 1 October 2025
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Albuquerque, New Mexico, United States

📋 Eligibility Criteria

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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ 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

  • First Submitted 17 October 2023
  • First Submitted that Met QC Criteria 30 October 2023
  • First Posted 2 November 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 12 June 2024
  • Last Update Posted 13 June 2024
  • Last Verified June 2024
I'm interested ...!!