Dietary Intervention in Type-2 Diabetics and Pre-Diabetics Emphasizing Personalized Carbohydrate Intake
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 465
- 试验地点
- 2
- 主要终点
- Change from Baseline Body Weight
研究概览
简要总结
The primary purpose of this research is to demonstrate the therapeutic effects of implementing a well-formulated low carbohydrate lifestyle program over 2 years in patients with type 2 diabetes, pre-diabetes, and metabolic syndrome.
详细描述
The primary purpose of this research is to demonstrate the therapeutic effects of implementing a well-formulated low carbohydrate lifestyle program over 2 years. Positive therapeutic effects would be represented by improved glycemic control in patients with type 2 diabetes without use of additional glycemic control medications and failure to progress to type 2 diabetes in individuals with pre-diabetes and metabolic syndrome.
Secondary purposes of this research are to determine if therapeutic effects of the intervention differ between patients who self-select onsite vs. web-based education delivery, explore relationships between change in LDL cholesterol and carotid intima media thickness, and to evaluate the sustainability of health outcomes achieved and the economic impact of therapeutic effects over 5 years.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body weight/Diabetes:
- •Diagnosis of type-2 diabetes with BMI > 25 (without end-organ failure)
- •Fasting glucose >126 mg/dL or HbA1c >6.5
- •Body weight/ Pre-diabetes:
- •Diagnosis of metabolic syndrome with BMI >30 and HbA1c > 5.6 (note: this does not apply to usual care control subjects)
- •Ethnicity: all ethnic groups
排除标准
- •BMI <30 without diagnosis of Type-2 diabetes, metabolic syndrome
- •Type 1 diabetes
- •History of keto-acidosis
- •History of MI, stroke, angina, coronary insufficiency within the last 6 months
- •Diabetic retinopathy requiring treatment
- •Creatinine > 2.0
- •Urinary albumin > 1 g/d
- •Impaired hepatic function (Bilirubin >2, Albumin < 3.5)
- •Cholelithiasis or biliary dysfunction
- •Cancer requiring treatment in the past 5 years, with the exception of non-melanoma skin cancer
- •Chronic infectious disease requiring ongoing treatment
- •Other chronic diseases or condition likely to limit lifespan to <6 years
- •Non-English speaking
- •Unable or unwilling to participate in group sessions (e.g., plans to relocate within the next year) or conform to a carbohydrate restricted diet lifestyle (e.g., food intolerances, religious or personal restrictions)
- •Weight loss of >10% in past 6 months
- •Currently pregnant or nursing, or planning to become pregnant during the study
- •Major psychiatric disorder (e.g., schizophrenia, bipolar disorder) currently uncontrolled
- •Excessive alcohol intake (acute or chronic) defined as average consumption of 3 or more alcohol-containing beverages daily or consumption of more than 14 alcoholic beverages per week
结局指标
主要结局
Change from Baseline Body Weight
时间窗: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
Body weight will be evaluated on a calibrated scale
Change from Baseline Type-2 Diabetes Status
时间窗: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
Type-2 diabetes status will be evaluated by measuring Hemoglobin A1c (HbA1c)
Change from Baseline Metabolic Syndrome Status
时间窗: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
Metabolic syndrome status will be evaluated by standard markers. Metabolic syndrome is defined as having at least three of the following: * Waist circumference: ≥40 inches (men) or ≥35 inches (women) * Fasting triglycerides: ≥150 mg/dL * HDL-C: \<40 mg/dL (men) or \<50 mg/dL (women) * Blood pressure: ≥130/85 mm Hg or use of hypertensive medication * Fasting glucose: ≥ 100 mg/dL or use of hyperglycemia medication
次要结局
- Change from Baseline Carotid Intima Media Thickness (CIMT) (intervention and usual care arms, participants with type 2 diabetes only)(12 and 24 Months)
- Change from Baseline Serum Lipids(3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms))
- Change from Baseline Body Composition(3,12 and 24 Months (intervention arms only))
- Change from Baseline Type-2 Diabetes Status(42 and 60 Months (intervention arms only))
- Change from Baseline Metabolic Syndrome Status(42 and 60 Months (intervention arms only))
- Change from Baseline Body Weight(42 and 60 Months (intervention arms only))