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临床试验/NCT06115265
NCT06115265招募中不适用

Ketogenic Diet and Diabetes Demonstration Project

University of New Mexico2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年9月5日最近更新:
适应症
干预措施

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

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

Experimental

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristen M Gonzales

Assistant Professor

University of New Mexico

研究点 (2)

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