Ketogenic Diet and Diabetes Demonstration Project

Obesity Clinical Trial

— KDDP  

Official title:

Ketogenic Diet and Diabetes Demonstration Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06115265
• Other study ID #: 22-364
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2023
• Est. completion date: October 1, 2025

Study information

• Verified date: June 2024
• Source: University of New Mexico
• Contact: Kristen M Gonzales, MD
• Phone: 505-272-3840
• Email: KrGonzales[@]salud.unm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Ketogenic Dieting
• Obesity
• PreDiabetes
• Prediabetic State
• Type 2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight in kg	Change in weight over 12-months in KDDP arm vs NDPP arm	12 months
Secondary	Blood pressure in mmHg	Changes in the above measures from baseline to 12 months in KDDP arm vs. NDPP arm	12 months
Secondary	Heart rate in beats per minute (BPM)	Changes in heart rate from baseline to 12 months in KDDP arm vs. NDPP arm	12 months
Secondary	HbA1c as a percent	Changes in HbA1c from baseline to 12 months in KDDP arm vs. NDPP arm	12 months
Secondary	Fasting lipids in mg/dL	Changes in fasting lipids from baseline to 12 months in KDDP arm vs. NDPP arm	12 months
Secondary	Fasting plasma glucose in mg/dL	Changes in fasting plasma glucose from baseline to 12 months in KDDP arm vs. NDPP arm	12 months
Secondary	CAC scores	Changes in CAC scores from baseline to 12 months in KDDP arm vs. NDPP arm	12 months