NCT02977039撤回不适用
Effect of a Nutrient Dense Plant Rich Diet on Glycemic Control in People With Type 2 Diabetes and Obesity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Glycemic control
研究概览
简要总结
The purpose of this study is to evaluate the effect of a nutrient dense plant rich (NDPR) diet compared to a standard USDA diet on glycemic control, inflammation, and cardiovascular risk in individuals with type 2 diabetes and overweight/obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ages 18-75
- •Type 2 diabetes mellitus diagnosed > 6 months prior to screening visit according to American Diabetes Association criteria
- •HBA1c >7.5% but < 10%
- •BMI >25 kg/m2 ; >23 kg/m2 for Asian subjects but < 45 kg/m2
- •Stable weight (variation < 5 kg within 6 months of screening visit)
- •Ability to give informed consent
- •Ability to follow verbal and written instructions in English
排除标准
- •Active cardiac issues: history of myocardial infarction within 3 months of screening visit, unstable angina pectoris, or Class III or Class IV congestive heart failure
- •Persistent uncontrolled hypertension (BP > 160/100 mmHg on or off antihypertensive medication)
- •Active marijuana or intravenous drug use
- •Recent weight loss (> 5 kg within 6 months of the screening visit)
- •Inflammatory or irritable bowel disease (Crohn's Disease, Ulcerative Colitis, or IBS)
- •Celiac disease
- •Malignancy treated with chemotherapy within the past 1 year
- •Depression or psychosis requiring hospitalization within 1 year, or use of major antipsychotic or tranquilizer drugs (i.e. benzodiazepines)
- •Renal insufficiency (creatinine clearance < 30 ml/min)
- •Transaminases > 2x above the normal range
- •Pregnancy within 6 months of the screening visit
- •History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling
- •History of alcohol abuse within the past 5 years
- •Vegetarian/Vegan diet
- •Dairy Allergy/Intolerance
- •Anemia, including iron deficient and megaloblastic
- •Vitamin B12 deficiency
- •Leber's disease
结局指标
主要结局
Glycemic control
时间窗: change at 1, 3, 6, 9, 12 months
A1C and finger stick blood sugar levels
次要结局
- hepatic steatosis(baseline, 1, 3, 6, 9, 12 months)
- body composition(change at 1,3,6,9, 12 months)
- quality of life(change at, 1, 3, 6, 9, 12 months)
- body weight(change at 1, 3, 6, 9, 12 months)
- inflammatory markers(change at, 1, 3, 6, 9, 12 months)
研究者
Martin Abrahamson
Principal Investigator
Beth Israel Deaconess Medical Center
研究点 (2)
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