Effect of Low Glycemic Index Diets (With Pulses) on Glucose Control in Non-Insulin Dependent Diabetics
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- change in HbA1c
研究概览
简要总结
Healthy individuals with type 2 diabetes will receive intensive counseling on food selection to improve glucose control using either high cereal fiber dietary strategies or low glycemic index foods emphasizing dried legumes and their products. The treatments will last 3 months with bloods taken for HbA1c, glucose and blood lipids. If the study shows a benefit for either or both diets, then use of high fiber and/or low glycemic index foods in the diet may provide another potential way to improve glucose control and lower cholesterol levels in non-insulin dependent diabetes.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women with type 2 diabetes who
- •are treated with oral hypoglycemic agents at a stable dose for at least 8 weeks
- •have a HbA1c in the range of 6.5% to 8.5% at screening and at the visit prior to randomization
- •have diabetes diagnosed >6 months
- •have maintained stable weight for 2 months (within 3%)
- •have a valid OHIP card and a family physician
- •if prescribed lipid medication, have taken a stable dose for at least 2 weeks
- •if prescribed blood pressure medication, have taken a stable dose for at least 1 week
- •can keep written food records, with the use of a digital scale
排除标准
- •Individuals who
- •take insulin
- •take steroids
- •have GI disease (gastroparesis, celiac disease, ulcerative colitis, Crohn's Disease, IBS)
- •have had a major cardiovascular event (stroke or myocardial infarction) in the past 6 months
- •take warfarin (Coumadin)
- •have had major surgery in the past 6 months
- •have a major debilitating disorder
- •have clinically significant liver disease (AST or ALT > 130 U/L), excluding NAFL or NASH
- •have hepatitis B or C
- •have renal failure (high creatinine > 150 mmol/L)
- •have serum triglycerides ≥ 6.0 mmol/L
- •have a history of cancer, except non-melanoma skin cancer (basal cell, squamous cell)
- •have food allergies to study food components
- •have elevated blood pressure (> 145/90) unless approved by GP
- •have acute or chronic infections (bacterial or viral)
- •have chronic inflammatory diseases (e.g. rheumatoid arthritis, lupus; ulcerative colitis)
- •have other conditions which in the opinion of any of the investigators would make them unsuitable for the study
研究组 & 干预措施
Low glycemic Index Diet
Low glycemic Index Diet, emphasizing pulses
干预措施: Low glycemic index diet with pulses (Dietary Supplement)
High Cereal Fibre Diet
干预措施: High Cereal Fibre (Dietary Supplement)
结局指标
主要结局
change in HbA1c
时间窗: from prestudy and week 0, to end of treatment weeks 8, 10, and 12
serum lipids
时间窗: from prestudy and week 0, to end of treatment weeks 8, 10, and 12
次要结局
- creatine, urea, and c-peptides in 24 hour urine collection(0, 12 weeks.)
- change in weight, waist and hip circumference(weeks 0, 12)
- fasting glucose(from prestudy and week 0, to end of treatment weeks 8, 10, and 12)
- blood pressure(from prestudy and week 0, to end of treatment weeks 8, 10, and 12)
研究者
David Jenkins
Principle Investigator
University of Toronto