Ketogenic Diet and Diabetes Demonstration Project

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Men and women ≥ 18 years old

• BMI ≥27 kg/m2

• Hemoglobin A1c ≥ 5.7% and/or fasting plasma glucose of 100-125 mg/dL

Locations
United States
New Mexico
University of New Mexico
RECRUITING
Albuquerque
Contact Information
Primary
Kristen M Gonzales, MD
KrGonzales@salud.unm.edu
505-272-3840
Backup
Matthew Bouchonville, MD
mbouchonville@salud.unm.edu
505-272-3840
Time Frame
Start Date: 2023-09-05
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 40
Treatments
Experimental: KDDP
KDDP - Participants enrolled in the KDDP arm will be placed on a traditional ketogenic diet (\<20 grams of carbohydrate/day).
Experimental: NDPP
NDPP - Participants enrolled in the NDPP arm will be placed on a low fat diet.
Related Therapeutic Areas
Sponsors
Leads: University of New Mexico

This content was sourced from clinicaltrials.gov

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