Ketogenic Diet and Diabetes Demonstration Project
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of New Mexico
About this trial
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 criteria
Qualifiers
Men and women ≥ 18 years old
BMI ≥27 kg/m2
Hemoglobin A1c ≥ 5.7% and/or fasting plasma glucose of 100-125 mg/dL
Disqualifiers
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
Trial design
Treatments tested in this trial
- Ketogenic diet
- Low Fat diet
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov