Effect of Low Glycemic Index Diets (With Canola Oil) 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
- 141
- 试验地点
- 2
- 主要终点
- change in serum lipids
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 especially canola oil containing bread. 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 with canola oil, may provide another potential way to improve glucose control and lower cholesterol levels in non-insulin dependent diabetes.
详细描述
Overall design
- Sample size justification: The sample size requirement was determined based on the ability to detect a HbA1c reduction of at least 0.4 units, significance of the test (α) of 0.05, β of 2 and power (1-β) of 0.80 (The FDA criterion for drug effectiveness is a HbA1c reduction of 0.3 to 0.4 units). Examination of recent study results for HbA1c of the research group on type 2 diabetic subjects indicated a standard deviation of 0.32. So the desired total number to complete this study is N=80, or 120 enrolled assuming a 30% attrition rate.
- Design: All subjects will be randomized to one of two 12-week treatments in a two-treatment parallel design. Treatments: 1) low glycemic index dietary advice (e.g. to eat intact grain cereals, Pita Break Finland Rye and Little Stream Quinoa breads, parboiled rice, cracked wheat, pasta, peas, beans, lentils, and baked goods made from legume flour), with particular emphasis on a canola oil containing bread; and a 2) high cereal fiber diet emphasizing whole grains.
Duration: The study will consist of approximately two months recruitment and patient selection, and a 3 month treatment period.
Study Details: Fasting blood samples are obtained at screening, week -2, 0, 2, 4, 8, 10 and 12 of each study period for glucose, lipids and oxidation products. HbA1c will be assessed on all visits except week 2. Twenty-four hour urine for urinary C-peptide, isoprostane, urea, creatinine and electrolyte analyses will be obtained immediately prior to the beginning of the study and at the end of the 12 week treatment. At weeks 0 (baseline) and 12, endothelial function will be assessed. Following the 12 week treatment period, subjects who wish to undertake the alternate treatment will be given appropriate instruction.
- Setting: Risk Factor Modification Center at St. Michael's Hospital.
- Participants/controls (selection and inclusion/exclusion criteria):
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 the initial screening visit and at the prestudy visit (visit just 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 canola oil, study food components
- •have elevated blood pressure (> 145/90) unless approved by General Practitioner (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
- •If HbA1c rises above 8.5% over two consecutive routine measurements, subjects will be referred back to their family doctors for an increase in anti hyperglycemic medications according to a predetermined protocol.
结局指标
主要结局
change in serum lipids
时间窗: from prestudy and week 0, to end of treatment weeks 8, 10, and 12
Change in HbA1c
时间窗: from prestudy and week 0, to end of treatment weeks 8, 10, and 12
次要结局
- change in blood pressure(from prestudy and week 0, to end of treatment weeks 8, 10, and 12)
- creatinine, urea, and c-peptides in 24 hour urine collection(0, 12 weeks)
- cancer cell proliferation (in vitro)(week 0, 12)
- fasting glucose(from prestudy and week 0, to end of treatment weeks 8, 10, and 12)
- change in weight, waist, and hip circumference(weeks 0 to 12)
- endothelial function(week 0, 12)
研究者
David Jenkins
Principle Investigator
University of Toronto