Effect of 12 Weeks Consumption of Sago Based Products in a Malaysian Diet on Glycaemic and Lipid Control in Diabetic Patients: a Double-Blind, Randomised, Parallel Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 8
- 主要终点
- Change of HbA1C value
研究概览
简要总结
This will be a parallel, randomised, double-blind, controlled trial. Upon successful screening, subjects will be randomised to either intervention arm or control arm in a ratio of 1:1. The subjects will consume either a drink containing 25g of Sarawak sago starch (intervention) or 25g of corn starch (control) in approximately 200mL of water, two times a day, before lunch and dinner for 12 weeks, in addition to a standardised dietary counselling for diabetes given by the hospital dietitian at baseline. The study endpoints will be evaluated after 12 weeks of starch consumption.
详细描述
SAGODM trial is a parallel, randomised, double-blind, controlled trial on the effect of consuming sago starch for 12 weeks on glycaemic and lipid control in patients with type 2 diabetes mellitus. Diabetic patients who had HbA1C between 6.5% and 8.5% and had no change in the antidiabetic treatment for the past two months (primary inclusion criteria) were invited to participate in the trial. They were randomised to either the intervention arm or control arm in a ratio of 1:1. The subjects will consume either a drink containing 25g of Sarawak sago starch (intervention) or 25g of corn starch (control) in approximately 200mL of water, two times a day, before lunch and dinner for 12 weeks. They will receive standardised dietary counselling for diabetes given by the hospital dietitian at baseline. They will also be asked to record their dietary intake for three consecutive days every month. Blood samples will be taken at baseline and the last visit (post-12 weeks). The study endpoints will be evaluated after 12 weeks of starch consumption.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Intervention (Sago starch) and control (corn starch) will be packed in individual aluminium sachets and will not be distinguishable from each other. The included subjects and investigators will be blinded from the study arm assignment. Randomisation and dispensation of the study starch will be done by the unblinded pharmacists only, who will not be involved in the care of the patients and study endpoint assessments.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 70 years old
- •Individual diagnosed with type 2 diabetes for at least three months
- •Not on any antidiabetic medications or on lifestyle modification or taking a stable dose of oral hypoglycaemic agents, with no change of dose and regime for the past eight weeks
- •Has HbA1C values of 6.5 - 8.5% within 28 days before commencing the study
- •Able to complete the clinical study, and
- •Able to provide written informed consent
排除标准
- •History of allergy to sago starch or corn starch
- •History of allergy to any other ingredients in the study foods
- •Clinically significant, active and acute cardiovascular disease
- •Clinically significant, stage 4 - 5 (estimated glomerular filtration rate <30mL/min/1.73m2), chronic kidney failure
- •Clinically significant chronic liver disease or infection
- •Any malignancies
- •Regular use of hormone medications, anti-inflammatory medication, steroids, or other medications that might interfere with outcome measure
- •On a prescribed therapeutic diet
- •Taking part in weight loss programme
- •Clinically significant abnormal laboratory investigations
- •Other medical conditions or reasons, in the opinion of the Investigator or Research Physician, that make one unsuitable to join the study
- •Concurrent participation in other clinical studies involving intervention or treatment towards obesity, diabetes or impaired glucose
- •Pregnant or lactating mothers
结局指标
主要结局
Change of HbA1C value
时间窗: 12 weeks
The change of HbA1C value at 12 weeks of intervention from baseline
Change of fasting blood glucose (FBG) level
时间窗: 12 weeks
The change of FBG level at 12 weeks of intervention from baseline
Change of homeostasis model assessment (HOMA) of insulin resistance (HOMA-IR) value
时间窗: 12 weeks
The change of HOMA of insulin resistant value at 12 weeks of intervention from baseline
Change of low density lipoprotein cholesterol (LDL-C) level
时间窗: 12 weeks
The change of LDL-C level at 12 weeks of intervention from baseline
Change of high density lipoprotein cholesterol (HDL-C) level
时间窗: 12 weeks
The change of HDL-C level at 12 weeks of intervention from baseline
Change of triglycerides level
时间窗: 12 weeks
The change of triglycerides level at 12 weeks of intervention from baseline
Change of total cholesterol level
时间窗: 12 weeks
The change of total cholesterol level at 12 weeks of intervention from baseline
次要结局
- Change of inflammatory marker levels: high-sensitive c-reactive protein (hs-CRP) level(12 weeks)
- Change of inflammatory marker levels: interleukin 6 (IL-6) level(12 weeks)
- Change of inflammatory marker levels: blood ferritin level(12 weeks)
- Change of body weight/body mass index (BMI)(12 weeks)
- Change of heart rate from baseline(12 weeks)
- Change of total daily calorie intake(12 weeks)
- Change of body fat and visceral fat percentages(12 weeks)
- Change of waist-hip ratio from baseline(12 weeks)
- Change of blood pressure from baseline(12 weeks)
研究者
Xun Ting Tiong
Medical Officer
Sarawak General Hospital