KDDP: Ketogenic Diet and Diabetes Demonstration Project

Sponsor

University of New Mexico (Other)

Overall Status

Recruiting

CT.gov ID

NCT06115265

Collaborator

(none)

Enrollment

Location

Arms

12.9

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes PreDiabetes Obesity Ketogenic Dieting	Behavioral: Ketogenic diet Behavioral: Low Fat diet	N/A

Detailed Description

KDDP is a prospective, 12-month pilot study comparing the effects of the KDDP vs. CDC NDPP in patients with obesity and dysglycemia. KDDP is the Ketogenic Diet and Diabetes Demonstration Project arm. Individuals enrolled in the KDDP arm will attend a mandatory Weight Management class through the Center for Diabetes and Nutrition Education, and they will participate in a standard comprehensive lifestyle intervention program that is identical to that of the NDPP with the exception of dietary recommendations. Individuals in the KDDP arm will be educated on and follow a ketogenic diet (<20g carbohydrates/day). They will receive guidance on tracking carbohydrate intake daily, and home point-of-care ketone breath testing will be performed at regular intervals to ensure that ketosis is being achieved and maintained. They will attend weekly educational sessions facilitated by trained dieticians. Individuals enrolled in the CDC NDPP arm will adhere to a low fat diet and receive identical follow up with the dieticians relative to those enrolled in the KDDP arm. Individuals in both arms will be matched for age, sex, weight, and A1c.

Baseline measures at study entry will include weight, height, systolic and diastolic blood pressure, heart rate, hemoglobin A1c, fasting plasma glucose, total cholesterol, triglycerides, HDL cholesterol, and LDL cholesterol. These parameters will be measured every 3 months throughout the study and at study completion. Additionally, participants in both groups will be consented to undergo CAC scanning at baseline and at 12 months to assess for any differences in dietary interventions on CAC scores.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Ketogenic Diet and Diabetes Demonstration Project

Actual Study Start Date :

Sep 5, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: KDDP KDDP - Participants enrolled in the KDDP arm will be placed on a traditional ketogenic diet (<20 grams of carbohydrate/day).	Behavioral: Ketogenic diet 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.
Experimental: NDPP NDPP - Participants enrolled in the NDPP arm will be placed on a low fat diet.	Behavioral: Low Fat diet 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.

Arm

Intervention/Treatment

Experimental: KDDP

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

Behavioral: Ketogenic diet

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.

Experimental: NDPP

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

Behavioral: Low Fat diet

Outcome Measures

Primary Outcome Measures

Weight in kg [12 months]
Change in weight over 12-months in KDDP arm vs NDPP arm

Secondary Outcome Measures

Blood pressure in mmHg [12 months]
Changes in the above measures from baseline to 12 months in KDDP arm vs. NDPP arm
Heart rate in beats per minute (BPM) [12 months]
Changes in heart rate from baseline to 12 months in KDDP arm vs. NDPP arm
HbA1c as a percent [12 months]
Changes in HbA1c from baseline to 12 months in KDDP arm vs. NDPP arm
Fasting lipids in mg/dL [12 months]
Changes in fasting lipids from baseline to 12 months in KDDP arm vs. NDPP arm
Fasting plasma glucose in mg/dL [12 months]
Changes in fasting plasma glucose from baseline to 12 months in KDDP arm vs. NDPP arm
CAC scores [12 months]
Changes in CAC scores from baseline to 12 months in KDDP arm vs. NDPP arm

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of New Mexico	Albuquerque	New Mexico	United States	87131

Sponsors and Collaborators

University of New Mexico

Investigators

Principal Investigator: Kristen Gonzales, MD, University of New Mexico

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kristen M Gonzales, Assistant Professor, University of New Mexico

ClinicalTrials.gov Identifier:

NCT06115265

Other Study ID Numbers:

22-364

First Posted:

Nov 2, 2023

Last Update Posted:

Nov 2, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Prediabetic State

Study Results

No Results Posted as of Nov 2, 2023