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临床试验/NCT00438698
NCT00438698已完成不适用

Effect of Low Glycemic Index Diets on Glucose Control in Non-Insulin Dependent Diabetics

University of Toronto2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2004年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
210
试验地点
2
主要终点
Change in Fasting Glucose

研究概览

简要总结

Large observational studies have shown cereal fiber to protect from diabetes and heart disease. Despite the success of acarbose, an α-glucosidase hydrolase inhibitor, which lowers the glycemic index of foods containing starch, sucrose and maltodextrins, the use of diets containing low glycemic index foods still remains to be established. We will therefore provide otherwise healthy individuals with type 2 diabetes intensive counseling on food selection either to improve glucose control using high cereal fiber dietary strategies or low glycemic index foods. Studies will last 6 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.

详细描述

Recruitment: Subjects will be recruited by placing advertisements in local newspapers and by distributing similar advertisements to the diabetes clinic and diabetes education programs.

Information Sessions: Approximately 1000 volunteers in groups of 10-30 with or without spouses will attend one of a number of evening information sessions run from the Risk Factor Modification Center at St. Michael's Hospital. During the sessions the exact nature of the study will be described and volunteers will have the opportunity to ask specific questions about the study and taste the high fiber and low glycemic index foods.

Screening: Potential subjects will then fill in and return to the investigators a detailed questionnaire concerning their medical history, medications (including vitamin, mineral and nutritional supplements) smoking habits, alcohol intake and exercise pattern and whether they are currently on a specific diet. Details will also be obtained concerning planned vacations. Those subjects deemed potentially eligible will be asked to give a fasting blood sample at the Risk Factor Modification Center. Individuals who meet the study criteria, are invited to return again to the Center. The principles of the diabetic diet which they are already expected to be following will be reinforced, which incorporate the key elements of an NCEP Step 2 diet (total calories from fat <30%, saturated fat <7%, polyunsaturated fat <10%, dietary cholesterol <200 mg/day).

All subjects will then be randomized to one 24-week treatment in a two-treatment parallel design.

Treatments: 1) low glycemic index dietary advice (e.g. to eat intact grain cereals, pumpernickel bread, parboiled rice, cracked wheat, pasta, peas, beans and lentils) 2) high cereal fiber diet. Background diets will be the subjects' diabetic diets, modified as above, which will conform to CDA and NCEP Step 2 guidelines. Diet histories will be recorded at weeks 0, 2, 4, 8, 12, 16 and 24. These diets will be assessed for consistency by the dietitian in the subject's presence. Where necessary, modifications in diet will be made to ensure weight maintenance. Compliance will be assessed by 7 day food records.

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
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and postmenopausal women with type 2 diabetes treated with diet plus oral hypoglycemic agents (Sulfonylureas, Biguanides, Thiazolidinediones , and new secretagogues (Repaglinide)) at a stable dose for at least 3 months prior to starting the study
  • HbA1c between 6.5 and 8.0% at recruitment
  • living within a 40 km radius of St. Michael's Hospital
  • Diabetes diagnosed > 6 months prior to randomization

排除标准

  • diabetic complications: clinically significant gastroparesis, retinopathy, nephropathy, neuropathy, hepatic disease, or CHD (current clinically significant CHD e.g. unstable angina)
  • taking insulin or acarbose
  • smoking or significant alcohol intake (> 1 drink/day)
  • serum triglycerides > 4.0 mmol/L

结局指标

主要结局

Change in Fasting Glucose

时间窗: 6 months

Change in Hemoglobin A1c

时间窗: 6 months

次要结局

  • CRP(6 months)
  • apo Lp(a)(6 months)
  • amino acids(6 months)
  • IGFBP-3(6 months)
  • apo B(6 months)
  • Change in Urinary creatinine(6 months)
  • Plasma lipids and lipoproteins (TG, LDL, HDL)(6 months)
  • urea(6 months)
  • serum FFA(6 months)
  • C-peptide(6 months)
  • IGF-I(6 months)
  • Serum apo AI(6 months)
  • Oxidized LDL(6 months)
  • Urinary C-peptide(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Jenkins

Professor

University of Toronto

研究点 (2)

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