Impact of a Pharmacist-led Therapeutic Nutritional Intervention on Medications and Glucose Control in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 2
- 主要终点
- Proportion of participants not on glucose-lowering medications
研究概览
简要总结
Type 2 diabetes represents a significant burden to both the individual and our healthcare system. Individuals with type 2 diabetes are typically prescribed one or more glucose-lowering medications, many of which have undesirable side effects (e.g., nausea, risk of cardiovascular complications, weight gain) and cost our healthcare system a lot of money. An alternative strategy to lower blood glucose is to consume a low-carbohydrate diet. However, adjusting medications after choosing to follow a low-carbohydrate diet can be difficult. Delivering a low-carbohydrate diet through pharmacists could circumvent this difficulty in medications adjustment because pharmacists are trained to adjust medications. In this study the investigators will determine whether type 2 diabetes patients can reduce medications and improve blood glucose by following a low-carbohydrate, low-calorie diet under the direction of a pharmacist.
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
盲法说明
Participants will know group assignments
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 30 and 75, have type 2 diabetes mellitus diagnosed by a physician, are taking one or more glucose-lowering medications, have a BMI ≥30, have no contraindications to following low-carbohydrate, energy-restricted, high-protein diet, and can read and speak English.
排除标准
- •Exlcusion criteria are:
- •Recent (within the last 2 years) diagnosis of coronary heart disease, stroke, or a heart attack.
- •Unstable cardiovascular disorder.
- •History of liver disease.
- •History of kidney disease or impaired renal function.
- •Previously undergone bariatric surgery.
- •Multiple sclerosis or other diagnosed neurological disease.
- •Currently pregnant or lactating, or planning on becoming pregnant in the next 12 months.
- •Any form of cancer within the last 5 years.
- •Body mass index (BMI) of <
- •Dietary restrictions that do not allow you to follow a low-carbohydrate, energy-restricted, high-protein diet (e.g., vegan, food allergies).
- •Any sensitivities to the ingredients in the pre-packaged foods
结局指标
主要结局
Proportion of participants not on glucose-lowering medications
时间窗: 12 weeks
Number of individuals taking no medications divided by the total number of participants.
次要结局
- Body mass(12 weeks)
- Hemoglobin A1C(12 weeks)
- Reduction in glucose-lowering medications(12 weeks)
- Body mass index(12 weeks)
- Waist circumference(12 weeks)
- Body fat percentage(12 weeks)
- Health related quality of life(12 weeks)
- Blood lipid profile(12 weeks)
- Fasting insulin(12 weeks)
- Fasting C-peptide(12 weeks)
- C-reactive protein(12 weeks)
- Liver enzymes(12 weeks)
- Fasting plasma glucose(12 weeks)
- Systolic Blood Pressure(12 weeks)
- Diastolic Blood Pressure(12 weeks)
- Reduction in non-glucose lowering medications(12 weeks)
研究者
Jonathan Little
Assistant Professor
University of British Columbia