Practice Based Nutrition Intervention-2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- hemoglobin A1C (diabetes management)
研究概览
简要总结
This study aims to test hypotheses that are potentially important to diabetes management, with practical implications for reducing the medical, personal, and economic costs of the disease. Anticipated outcomes include reductions in glycosylated hemoglobin that are significantly greater than those achievable with current diet recommendations, reductions in medication use among many intervention-group participants, beneficial changes in body weight and serum lipid concentrations, and a demonstration of the acceptability of the intervention diet. Progress toward these goals could refine dietary guidance for individuals with diabetes, increase treatment expectations, and reduce the massive burden the disease currently imposes.
The study further attempts to translate a dietary intervention studied in a clinical research setting to a medical practice. This will contribute to developing a model for diabetes care that can be used widely.
详细描述
Specific Aim 1 tests the hypothesis that the nutrition intervention (low-fat, low-GI, vegan diet; henceforth called the 'vegan diet') improves glycemic control, body weight, plasma lipid concentrations, blood pressure, and indices of renal function in a within-group analysis.
Glycosylated hemoglobin is the primary dependent variable, as well as fasting plasma glucose and urinary albumin and creatinine concentrations. The within-group changes in these variables from baseline to week 20, one-year follow-up will be compared.
Specific Aim 2 tests the hypothesis that the vegan diet is more effective than standard nutrition care for improving glycemic control, body weight, plasma lipid concentrations, blood pressure, and indices of renal function in individuals with type 2 diabetes.
Glycosylated hemoglobin is the primary dependent variable, as well as fasting plasma glucose and urinary albumin and creatinine concentrations in both the intervention and control groups. The between-groups differences in the changes in these variables from baseline to week 20, and one-year follow-up will be compared.
Specific Aim 3 tests the hypothesis that the vegan diet is sustainable among individuals with type 2 diabetes for a 20-week period, with weekly classes, and in a follow-up period of one year with limited professional support.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a diagnosis of type 2 diabetes mellitus, as defined by a fasting plasma glucose concentration ≥126 mg/dl on 2 occasions or a prior physician's diagnosis of type 2 diabetes with the use of hypoglycemic medications for at least 6 months
- •male or female
- •A1c between 6.5% and 10.5%
- •age at least 18 years
- •ability and willingness to participate in all components of the study
- •willingness to be assigned to either a low-fat, vegan diet or to standard care
- •diabetes medications unchanged for 1 month prior to volunteering for the study
- •patient of Dr. Mark Sklar
排除标准
- •body mass index >45 kg/m2
- •alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
- •use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)
- •history of severe mental illness (with current unstable status)
- •likely to be disruptive in group sessions (as determined by research staff)
- •Signs/symptoms of acute uncontrolled diabetes (including but not limited to polyuria, polydipsia, blurred vision, uncontrolled weight loss)
- •unstable medical status
- •already following a low-fat, vegetarian diet
- •an inordinate fear of blood draws
- •inability to maintain current medication regimen
- •lack of English fluency
研究组 & 干预措施
Vegan Group
Participants in the intervention group will follow a low-fat, vegan diet for 20 weeks, and will attend nutrition classes in the form of a weekly support group.
干预措施: Vegan diet (Other)
American Diabetes Association guidelines
Participants will follow ADA diet according to ADA regulations. This group will also receive weekly nutrition classes.
干预措施: American Diabetes Association guidelines (Other)
结局指标
主要结局
hemoglobin A1C (diabetes management)
时间窗: 20 weeks
次要结局
- Glucose(20 Weeks)
- Eating Inventory(20 Weeks)
- CESD-R (Center for Epidemiologic Studies Depression Scale: Review and revision)(20 Weeks)
- Dietary Acceptability(20 Weeks)
- 3-day dietary records(20 Weeks)
- International Physical Activity Questionnaire(20 Weeks)
- Food Acceptability Questionnaire(20 Weeks)
- Urinary albumin and creatinine(20 Weeks)
- Genotyping for Taq1 A and Taq1 B polymorphisms, and APOE (Apolipoprotein E)(20 Weeks)
- Waist and hip circumference(20 Weeks)
- Comprehensive Metabolic Panel(20 Weeks & one-year follow up)
- Body Weight(20 Weeks)
- Blood Pressure(20 Weeks)
- Serum cholesterol and triacylglycerol concentrations(20 Weeks)
- Beck Depression Inventory II (BDI-II)(20 Weeks)
- Height(20 Weeks)
- 24-Hour Multi-Pass Dietary Recalls(20 Weeks)