Ketogenic Diet and Diabetes Demonstration Project

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Weight in kg [Срок оценки: 12 months]

Вторичные конечные точки (6)

• Blood pressure in mmHg [Срок оценки: 12 months]
• Heart rate in beats per minute (BPM) [Срок оценки: 12 months]
• HbA1c as a percent [Срок оценки: 12 months]
• Fasting lipids in mg/dL [Срок оценки: 12 months]
• Fasting plasma glucose in mg/dL [Срок оценки: 12 months]
• CAC scores [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Men and women ≥ 18 years old
• BMI ≥27 kg/m2
• Hemoglobin A1c ≥ 5.7% and/or fasting plasma glucose of 100-125 mg/dL

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of New Mexico — Albuquerque

Идентификаторы

NCT: NCT06115265 · 22-364

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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