Clinical trial NCT06115265: Ketogenic Diet and Diabetes Demonstration Project
Official title: Ketogenic Diet and Diabetes Demonstration Project
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
PreDiabetes
Obesity
Ketogenic Dieting
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight in kg
timeFrame: 12 months
Secondary outcomes:
measure: Blood pressure in mmHg
timeFrame: 12 months
measure: Heart rate in beats per minute (BPM)
timeFrame: 12 months
measure: HbA1c as a percent
timeFrame: 12 months
measure: Fasting lipids in mg/dL
timeFrame: 12 months
measure: Fasting plasma glucose in mg/dL
timeFrame: 12 months
measure: CAC scores
timeFrame: 12 months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Kristen Gonzales, MD
role: PRINCIPAL_INVESTIGATOR
References: