Effects of a 12-Week Very-Low-Carbohydrate Diet on Body Composition and Cardiometabolic Outcomes in Adults With Prediabetes and Obesity: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change From Baseline in Body Weight at Week 12
研究概览
简要总结
Prediabetes is a condition where blood sugar is higher than normal but not yet high enough to be called type 2 diabetes. It is common in adults who are overweight or obese, and without treatment it often progresses to diabetes over time.
This study looks at whether following a very-low-carbohydrate diet for 12 weeks can help adults with prediabetes and obesity lose weight, reduce body fat, and improve how well their body responds to insulin, compared with standard dietary advice.
Adults aged 30 to 65 with obesity and newly diagnosed prediabetes are invited to take part. Participants are randomly assigned to one of two groups: one follows a very-low-carbohydrate diet with support from a dietitian, and the other receives standard dietary advice without a specific carbohydrate limit. Both groups are followed for 12 weeks, during which their weight, body composition, blood sugar, insulin levels, cholesterol, and kidney function are checked.
The study aims to find out whether the very-low-carbohydrate diet leads to greater improvements in weight, body fat, and insulin sensitivity than standard advice, and whether it is safe and practical to follow in everyday life. The findings may help doctors and dietitians offer more effective ways to prevent prediabetes from progressing to type 2 diabetes.
详细描述
Obesity and prediabetes frequently coexist and share a common pathophysiological pathway: excess visceral adiposity promotes chronic low-grade inflammation and insulin resistance, accelerating progression from normoglycaemia to prediabetes and ultimately to type 2 diabetes mellitus (T2DM). While carbohydrate-restricted dietary interventions have demonstrated efficacy for weight loss and glycaemic improvement in patients with established T2DM and diabetic kidney disease, their effects have not been well characterised in the earlier, potentially reversible stage of prediabetes, where intervention may carry the greatest preventive value.
This single-centre, randomized controlled trial evaluates the effects of a 12-week very-low-carbohydrate diet (VLCBD, less than 50 g carbohydrate/day) compared with standard dietary advice (no specific carbohydrate restriction) in adults with obesity and prediabetes attending a tertiary endocrine outpatient clinic in Malaysia. Both study arms receive individualised caloric intake based on ideal body weight, structured dietary counselling, and food diaries for adherence monitoring.
The study compares the two dietary approaches with respect to anthropometric and body composition changes, insulin resistance, and the safety and feasibility of the VLCBD approach over the 12-week intervention period, with assessments at baseline and at Week 12. Findings are intended to inform whether carbohydrate restriction is a feasible, safe, and effective dietary strategy for reducing cardiometabolic risk and preventing progression to type 2 diabetes in adults with prediabetes and obesity - a population not directly addressed by prior low-carbohydrate diet trials, which have been conducted mainly in patients with established diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30 to 65 years
- •Body mass index (BMI) 23-40 kg/m²
- •Diagnosis of prediabetes, defined as fasting blood glucose (FBG) 5.6-6.9 mmol/L or glycated haemoglobin (HbA1c) 5.6-6.2%
- •Able to stand independently
- •Able to provide written informed consent
排除标准
- •Diagnosis of type 1 or type 2 diabetes mellitus
- •Calculated creatinine clearance <60 mL/min/1.73 m²
- •on antiobesity medications
- •On medications that can interfere with glucose metabolism
- •Heart failure, New York Heart Association (NYHA) functional class III-IV
- •Active systemic inflammatory disease
- •Chronic kidney disease requiring haemodialysis
- •Active hepatic disease
- •Collagen vascular disease
- •Malignancy
- •Acute coronary syndrome within the preceding 3 months
- •Pregnancy or breastfeeding
- •Plans to conceive within the following year
研究组 & 干预措施
Standard Dietary Advice
Participants received standard dietary advice with no specific carbohydrate restriction, with total caloric intake individualised to ideal body weight, the same dietitian counselling, and food diaries, for 12 weeks.
干预措施: Standard Dietary Advice (Behavioral)
Very-Low-Carbohydrate Diet (VLCBD)
Participants received a very-low-carbohydrate diet (<50 g carbohydrate/day), with total caloric intake individualised to ideal body weight, structured dietitian counselling, and food diaries, for 12 weeks.
干预措施: Very-Low-Carbohydrate Diet (VLCBD) (Behavioral)
结局指标
主要结局
Change From Baseline in Body Weight at Week 12
时间窗: Baseline and Week 12
Body weight was measured in kilograms (kg) using a calibrated digital scale, with participants in light clothing and without shoes.
Change From Baseline in Body Mass Index (BMI) at Week 12
时间窗: Baseline and Week 12
BMI was calculated as weight in kilograms divided by height in meters squared (kg/m²).
Change From Baseline in Waist Circumference at Week 12
时间窗: Baseline and Week 12
Waist circumference was measured in centimetres (cm) at the midpoint between the lowest rib and the iliac crest.
Change From Baseline in Body Fat Percentage at Week 12
时间窗: Baseline and Week 12
Body fat percentage was measured using bioelectrical impedance analysis expressed as a percentage of total body weight.
次要结局
- Change in HOMA-IR(Baseline and week 12)
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12(Baseline and Week 12)
- Participant Retention Rate at Week 12(Baseline and Week 12)
研究者
Rohana Abdul Ghani
Professor
Universiti Teknologi Mara