Ketogenic Diet and Diabetes Demonstration Project
University of New Mexico
40 participants
Sep 5, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria10
- 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
Interventions
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06115265