Implementation of a Very Low Calorie Diet for Remission of Type 2 Diabetes in the Community
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- change in weight
研究概览
简要总结
The complications associated with uncontrolled type-2 diabetes mellitus (T2DM) are numerous; reducing the quality of life for the patient and consuming a considerable portion of healthcare finances.
The Health of the Nation (HotN) 2011 study reported that 50% of the Barbadian population >65years old had a diagnosis of T2DM and that two-thirds of the population were overweight - which is a risk factor for the development of T2DM.
Encouraged by the success of the Counterpoint study in the United Kingdom (UK), the Barbados Diabetes Reversal Study 1 (BDRS1) was established using a similar protocol; the aim of which was to evaluate the feasibility of implementing a very low calorie diet to reverse T2DM in Barbados. At the end of the 8-week intervention period, the 25 participants had achieved an average weight loss of 10.1kg (22lbs). This was accompanied by an increase in the number of participants whose fasting blood sugars were now within normal range despite being off of their diabetes medication; and a decrease in the number of participants taking blood pressure medication. Participants transitioned to a solid diet over a 4-week period, with guidance on health dietary habits and regular exercise routines. The benefits accrued during the intervention phase were preserved at the end of the transition period.
We now propose the Barbados Diabetes Remission Study 2 (BDRS2) as a sustainable community intervention - utilizing the local church as the community site. We hypothesize that this will enhance reach while reducing the cost of the study and will also facilitate the structures necessary for the social support of the participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 20 - 70 years old, all ethnicities
- •Diagnosis of T2DM for <6 years as defined by the American Diabetes Association
- •Diagnosis of pre-diabetes as defined by the American Diabetes Association
- •Body Mass index (BMI) of 27 kg/m2 and over
排除标准
- •Insulin use
- •Substance abuse
- •Current cancer diagnosis
- •myocardial infarction within last 6 month
- •learning difficulties
- •current treatment with anti-obesity drugs
- •diagnosed eating disorder or purging
- •HbA1c > 10%
- •pregnant/considering pregnancy
- •evidence of liver disease (including liver enzymes > 3 times above normal values)
- •evidence of renal disease (creatinine of > 150 mmol/l)
- •persons who have required hospitalisation for depression, or are on antipsychotic drugs
研究组 & 干预措施
very low calorie liquid diet
Phase 1: Caloric restriction Phase 2: Solid diet Phase 3: Transition to independence
干预措施: very low calorie liquid diet (Other)
结局指标
主要结局
change in weight
时间窗: enrolment, 12 weeks, 6 mths and 1 year
change in fasting glucose
时间窗: Enrolment, 12 weeks, 6 months, 1 year
change in Hba1C
时间窗: Enrolment, 12 weeks, 6 months, 1 year
次要结局
- change in blood pressure(Enrolment, 12 weeks, 6 months, 1 year)
- change in blood pressure medication(weekly for the first 12 weeks)
- change in waist circumference(Enrolment, 12 weeks, 6 months, 1 year)