NCT06115265

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
4mo left

Started Sep 2023

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Sep 2023Oct 2026

Study Start

First participant enrolled

September 5, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 17, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

2.7 years

First QC Date

October 17, 2023

Last Update Submit

June 18, 2025

Conditions

Type 2 DiabetesPreDiabetesObesityKetogenic Dieting

Outcome Measures

Primary Outcomes (1)

  • Weight in kg

    Change in weight over 12-months in KDDP arm vs NDPP arm

    12 months

Secondary Outcomes (6)

  • Blood pressure in mmHg

    12 months

  • Heart rate in beats per minute (BPM)

    12 months

  • HbA1c as a percent

    12 months

  • Fasting lipids in mg/dL

    12 months

  • Fasting plasma glucose in mg/dL

    12 months

  • +1 more secondary outcomes

Study Arms (2)

KDDP

EXPERIMENTAL

KDDP - Participants enrolled in the KDDP arm will be placed on a traditional ketogenic diet (\<20 grams of carbohydrate/day).

Behavioral: Ketogenic diet

NDPP

EXPERIMENTAL

NDPP - Participants enrolled in the NDPP arm will be placed on a low fat diet.

Behavioral: Low Fat diet

Interventions

Ketogenic dietBEHAVIORAL

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
Low Fat dietBEHAVIORAL

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.

NDPP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women ≥ 18 years old
  • BMI ≥27 kg/m2
  • Hemoglobin A1c ≥ 5.7% and/or fasting plasma glucose of 100-125 mg/dL

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Prediabetic StateObesity

Interventions

Diet, KetogenicDiet, Fat-Restricted

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Kristen Gonzales, MD

    University of New Mexico

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristen M Gonzales, MD

CONTACT

505-272-3840KrGonzales@salud.unm.edu

Matthew Bouchonville, MD

CONTACT

505-272-3840mbouchonville@salud.unm.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Subjects will be recruited to participate in either KDDP or NDPP. The lifestyle interventions are identical with the exception of dietary recommendations. Groups will be matched according to age, sex, and HbA1c.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 17, 2023

First Posted

November 2, 2023

Study Start

September 5, 2023

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Individual data will not be shared with researchers outside of those directly conducting this study.

Locations

US(1)