Ketogenic Diet and Diabetes Demonstration Project

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes; PreDiabetes; Obesity; Ketogenic Dieting
• Interventions: Behavioral: Ketogenic diet; Behavioral: Low Fat diet

• Registration Number: NCT06115265
• Lead Sponsor: University of New Mexico

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.

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 Timeline

• Study Start: 2023-09-05
• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-30
• Study First Posted: 2023-11-02
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-13
• Primary Completion: 2025-05-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Weight in kg	12 months	Change in weight over 12-months in KDDP arm vs NDPP arm

Secondary Outcome Measures

Name	Time	Method
CAC scores	12 months	Changes in CAC scores 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 plasma glucose in mg/dL	12 months	Changes in fasting plasma glucose from baseline to 12 months in KDDP arm vs. NDPP arm
Blood pressure in mmHg	12 months	Changes in the above measures 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

Trial Locations

Locations (1)

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States