Obesity Clinical Trial
— KDDPOfficial title:
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | October 1, 2025 |
Est. primary completion date | May 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of New Mexico | Albuquerque | New Mexico |
Lead Sponsor | Collaborator |
---|---|
University of New Mexico |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight in kg | Change in weight over 12-months in KDDP arm vs NDPP arm | 12 months | |
Secondary | Blood pressure in mmHg | Changes in the above measures from baseline to 12 months in KDDP arm vs. NDPP arm | 12 months | |
Secondary | Heart rate in beats per minute (BPM) | Changes in heart rate from baseline to 12 months in KDDP arm vs. NDPP arm | 12 months | |
Secondary | HbA1c as a percent | Changes in HbA1c from baseline to 12 months in KDDP arm vs. NDPP arm | 12 months | |
Secondary | Fasting lipids in mg/dL | Changes in fasting lipids from baseline to 12 months in KDDP arm vs. NDPP arm | 12 months | |
Secondary | Fasting plasma glucose in mg/dL | Changes in fasting plasma glucose from baseline to 12 months in KDDP arm vs. NDPP arm | 12 months | |
Secondary | CAC scores | Changes in CAC scores from baseline to 12 months in KDDP arm vs. NDPP arm | 12 months |
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