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Ketogenic Diet and Diabetes Demonstration Project

RECRUITINGN/ASponsored by University of New Mexico
Actively Recruiting
PhaseN/A
SponsorUniversity of New Mexico
Started2023-09-05
Est. completion2026-05-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT06115265

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions5

DiabetesKetogenic DietingObesityPreDiabetesType 2 Diabetes

Locations1 site

University of New Mexico
Albuquerque, New Mexico, 87131
Kristen Gonzales, MD5052723840KrGonzales@salud.unm.edu

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