Ketogenic Diet and Diabetes Demonstration Project

Part of paid clinical trials in Albuquerque, New Mexico.

Sponsor
University of New Mexico
Study ID
NCT06115265
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Ketogenic diet — BEHAVIORAL
    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.
  • Low Fat diet — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Sep 5, 2023
Status verified
Jun 2025
Primary completion
May 30, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Weight in kg [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of New MexicoAlbuquerqueNew Mexico87131
Kristen Gonzales, MD
[email protected]
5052723840
Matthew Bouchonville, MD
[email protected]
5052723840

Find similar trials in Albuquerque, NM

By condition
Obesity / overweightType 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of New Mexico· Albuquerque, NM

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