Effectiveness of a Weight Management Programme on Diabetes Remission in Obese Patients With Early Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Diabetes Remission
研究概览
简要总结
The goal of this clinical trial is to determine the effectiveness of a weight management programme in primary care in achieving diabetes remission in obese patients with early diabetes.
Potential participants are to attend a screening visit to determine eligibility. Eligible participants will be invited to participate in the trial within 3 months of screening visit. 120 participants will be recruited into the study and randomised into 2 arms: control group (60 participants) or intervention group (60 participants).
Control group: Participants randomised to the control group will receive usual care with their healthcare team.
Intervention group: Participants randomised to the intervention group will be put on a weight management programme with the aim of achieving weight loss of at least 15% body weight or 15kg.
Researchers will compare between control and intervention groups to see if a weight management programme is effective in achieving diabetes remission in obese patients with early diabetes, compared to usual care.
详细描述
CONTROL GROUP
Participants randomised to the control group will receive usual care that does not include very low calorie diet (VLCD). They will be offered up to 6 dietitian consultations and 6 nurse diabetes counselling sessions (optional) over 18 months (78 weeks). They will be provided a wearable device to monitor their physical activity.
INTERVENTION GROUP
Phase A - Very low calorie diet (VLCD) phase (800kcal/day) (12 weeks)
- A commercially available micronutrient-replete 840kj/201kcal liquid formula diet (shakes) will be provided (Optifast, Nestle Health Science) to replace usual foods, with ample fluids for 12 weeks.
- Soluble fibre supplements (Fybogel 2 x 3.5 g/day) will be provided to participants to reduce constipation.
- Oral hypoglycaemic agents will be withdrawn at the start of this phase. Oral hypoglycaemic agents may be reintroduced if blood glucose levels are found to be persistently elevated.
- Participants who are on antihypertensive medications will have their antihypertensive medications withdrawn. Blood pressure will be closely monitored in these participants and antihypertensives reintroduced if blood pressure levels are found to be persistently elevated.
- During this phase, continuous glucose monitoring will be carried out for the first 2 weeks.
- After the first 2 weeks of this phase, participants are encouraged to monitor their glucose levels (fasting or random) using a glucometer 2 times a week.
- If they achieve BMI below 21kg/m2 or 15% body weight loss or 15kg weight loss before 12 weeks, they will be moved into the LCD phase.
- During the VLCD phase, participants will be encouraged to maintain their usual physical activities, but not increase physical activity.
- Each participant will be provided a wearable device to monitor their physical activity levels.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Singaporean citizen or Singaporean Permanent Resident
- •Age between 21 to 60 years old
- •BMI between 27 to 45kg/m2
- •Type 2 Diabetes Mellitus diagnosis of less than 5 years duration
- •Recent HbA1c more than or equals to 6.5% if patient is on diet management alone
- •Recent HbA1c more than or equals to 6.1% if patient is on treatment with oral hypoglycaemic agents
- •Able to consume food products containing fish oil
- •Able to consume dairy products
- •Able to commit to study duration
排除标准
- •Current insulin use
- •Current treatment with anti-obesity drugs
- •Recent HbA1c more than or equals to 12%
- •Recent eGFR < 60 mL/min/1.73m2
- •History of diabetic retinopathy
- •History of ischaemic heart disease, myocardial infarction or cardiac failure
- •History of cerebrovascular event
- •Known liver cirrhosis
- •Known cancer not in remission
- •Active gout
- •Active gallstone disease or known asymptomatic gallstones
- •History of diagnosed eating disorder
- •History of hospitalisation for depression or on antidepressants within the past 6 months
- •Significant previously diagnosed psychiatric disorder eg schizophrenia, obsessive compulsive disorder
- •History of substance abuse, including alcohol use disorder
- •Women who are pregnant, or are considering pregnancy within the following 18 months
- •Women who are breastfeeding, or are considering breastfeeding within the following 18 months
- •Current participation in another research trial
结局指标
主要结局
Diabetes Remission
时间窗: 12 months (52 weeks)
Percentage of participants achieving HbA1c \<6.5% without medications
Weight Loss
时间窗: 12 months (52 weeks)
Percentage of participants achieving weight loss of 15% or 15kg or more
次要结局
未报告次要终点
研究者
Wern Ee Tang
Director, Clinical Research Unit and Information Management and Analytics
National Healthcare Group Polyclinics