Ketogenic Diet and Diabetes Demonstration Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Weight in kg
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women ≥ 18 years old
- •BMI ≥27 kg/m2
- •Hemoglobin A1c ≥ 5.7% and/or fasting plasma glucose of 100-125 mg/dL
排除标准
- •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
研究组 & 干预措施
KDDP
KDDP - Participants enrolled in the KDDP arm will be placed on a traditional ketogenic diet (<20 grams of carbohydrate/day).
干预措施: Ketogenic diet (Behavioral)
NDPP
NDPP - Participants enrolled in the NDPP arm will be placed on a low fat diet.
干预措施: Low Fat diet (Behavioral)
结局指标
主要结局
Weight in kg
时间窗: 12 months
Change in weight over 12-months in KDDP arm vs NDPP arm
次要结局
- CAC scores(12 months)
- Heart rate in beats per minute (BPM)(12 months)
- HbA1c as a percent(12 months)
- Fasting plasma glucose in mg/dL(12 months)
- Blood pressure in mmHg(12 months)
- Fasting lipids in mg/dL(12 months)
研究者
Kristen M Gonzales
Assistant Professor
University of New Mexico
