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Ketogenic Diet and Diabetes Demonstration Project

ConditionsType 2 DiabetesPreDiabetesObesityKetogenic Dieting
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: KDDPExperimental treatment 1 intervention
Group B: NDPPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Weight in kg

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

Time frame
12 months

Secondary outcomes

1

Blood pressure in mmHg

Changes in the above measures from baseline to 12 months in KDDP arm vs. NDPP arm

Time frame
12 months
2

Heart rate in beats per minute (BPM)

Changes in heart rate from baseline to 12 months in KDDP arm vs. NDPP arm

Time frame
12 months
3

HbA1c as a percent

Changes in HbA1c from baseline to 12 months in KDDP arm vs. NDPP arm

Time frame
12 months
4

Fasting lipids in mg/dL

Changes in fasting lipids from baseline to 12 months in KDDP arm vs. NDPP arm

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of New Mexico

Lead sponsor

Source ClinicalTrials.gov
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