NCT07710274尚未招募不适用
Effectiveness of the Personalized Responses & Integrated Systems for Metabolism (PRISM) on Improving Insulin Resistance Among Adults With Metabolic Syndrome: A Pilot Study (PRISM-I)
National University Health System, Singapore1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
研究概览
简要总结
The primary objective of the Personalized Responses & Integrated Systems for Metabolism (PRISM-I) pilot study is to assess the feasibility of conducting a definitive randomized controlled trial evaluating precision lifestyle interventions for improving insulin resistance in adults with metabolic syndrome.
详细描述
Specific objectives are to:
- Evaluate the feasibility and acceptability of the PRISM intervention and study procedures, including participant recruitment, retention, adherence, intervention delivery, and digital platform usability.
- Explore the preliminary effects of the four lifestyle interventions (time-restricted eating, increased physical activity, low-glycaemic load diet, and sleep hygiene) on insulin resistance, measured using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).
- Examine the preliminary effects of the interventions on biochemical, anthropometric, behavioural, cognitive, and psychological outcomes.
- Explore the potential behavioural and physiological pathways through which the lifestyle interventions may influence insulin resistance to inform the design of the definitive PRISM trial.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be included for if they are:
- •(1) adults aged 21-70 years old;
- •(2) willing and able to comply with using a CGM, smart ring, food logging app
- •(3) able to provide written informed consent;
- •(4) English-speaking and literate;
- •(5) meet the inclusion criteria for metabolic syndrome and insulin resistance.
- •The criteria for insulin resistance is HOMA-IR ≥ 2.
- •The criteria for metabolic syndrome is to have high waist circumference (≥ 80cm for females and ≥ 90cm for males); and any two of the four below:
- •(1) raised triglycerides: 1.7 mmol/L or on treatment;
- •(2) reduced HDL cholesterol: < 1.0 mmol/L (40 mg/dL) in men, < 1.3 mmol/L (50 mg/dL) in women, or on treatment;
- •(3) high blood pressure: 130/85 mmHg or on treatment; or
- •(4) raised fasting glucose: 5.6 mmol/L (100 mg/dL) or previously diagnosed with T2DM
排除标准
- •Participants will be excluded from both phases if they are:
- •(1) on insulin therapy;
- •(2) are pregnant or lactating;
- •(3) have a medical condition or are on a treatment that may interfere with study participation or metabolic assessments, as determined by the study investigators;
- •(4) currently participating in other lifestyle modification programs.
结局指标
主要结局
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
时间窗: At baseline, Week 10
Insulin resistance will be assessed using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated as: HOMA-IR = (fasting plasma insulin × fasting plasma glucose) / 22.5 Higher HOMA-IR values indicate greater insulin resistance, whereas lower values indicate improved insulin sensitivity (reduced insulin resistance).
次要结局
- Glycated haemoglobin (HbA1c) (%)(At baseline, Week 10)
- Fasting plasma glucose (mmol/L)(At baseline, Week 10)
- Fasting Insulin (µIU/mL)(At baseline, Week 10)
- Total cholesterol (mmol/L)(At baseline, Week 10)
- High-density lipoprotein cholesterol (HDL-C) (mmol/L)(At baseline, Week 10)
- Low-density lipoprotein cholesterol (LDL-C) (mmol/L)(At baseline, Week 10)
- Cholesterol/HDL ratio(At baseline, Week 10)
- Triglycerides (mmol/L)(At baseline, Week 10)
- Lipoprotein a (nmol/L)(At baseline, Week 10)
- Apolipoprotein A1 (g/L)(At baseline, Week 10)
- Apolipoprotein B (g/L)(At baseline, Week 10)
- Apolipoprotein B/ A1 ratio(At baseline, Week 10)
- High-sensitivity C-reactive protein (hs-CRP) (mg/L)(At baseline, Week 10)
- Total protein (g/L)(At baseline, Week 10)
- Albumin (g/L)(At baseline, Week 10)
- Globulin (g/L)(At baseline, Week 10)
- A/G ratio(At baseline, Week 10)
- Bilirubin (µmol/L)(At baseline, Week 10)
- Alkaline phosphatase (ALP) (U/L)(At baseline, Week 10)
- Alanine aminotransferase (ALT/SGPT) (U/L)(At baseline, Week 10)
- Aspartate aminotransferase (AST/SGOT) (U/L)(At baseline, Week 10)
- Blood pressure (mmHg)(At baseline, Week 10)
- Montreal Cognitive Assessment (MoCA)(At baseline, Week 10)
- Hand grip strength (kg)(At baseline, Week 10)
- Weight (kg)(At baseline, Weeks 5,10)
- Waist circumference (cm)(At baseline, Weeks 5,10)
- Body mass index (BMI) (kg/m²)(At baseline, Weeks 5,10)
- Percentage Body Fat (%)(At baseline, Weeks 5,10)
- Body Fat Mass (kg)(At baseline, Weeks 5,10)
- Visceral Fat Level(At baseline, Week 10)
- ABSI (body shape index)(At baseline, Weeks 5,10)
- BRI (body roundness index)(At baseline, Weeks 5,10)
- Three Factor Eating Questionnaire (TFEQ)(At baseline, Week 10)
- International Physical Activity Questionnaire Short-Form (IPAQ-SF)(At baseline, Week 10)
- Generalized Anxiety Disorder 7-item (GAD-7)(At baseline, Week 10)
- Patient Health Questionnaire-9 (PHQ-9)(At baseline, Week 10)
- Perceived Stress Scale (PSS-10)(At baseline, Week 10)
- Heart rate recovery (beats/min)(Baseline through Week 10)
- Big Five Inventory - 44 item (BFI-44)(At baseline, Week 10)
- Sleep Hygiene Index (SHI)(At baseline, Week 10)
- Gut microbiome(At baseline, Week 10)
- Resting heart rate (beats/min)(Baseline through Week 10)
- Heart rate variability (ms)(Baseline through Week 10)
- Sleep duration (hours)(Baseline through Week 10)
- Sleep quality score (0-100)(Baseline through Week 10)
- Daily step count (steps/day)(Baseline through Week 10)
- Activity intensity minutes (minutes/day)(Baseline through Week 10)
- Energy expenditure (kcal/day)(Baseline through Week 10)
- Mean glucose (mmol/L)(Baseline through Week 10)
- Coefficient of variation (%)(Baseline through Week 10)
- Time Below Range (TBR, %)(Baseline through Week 10)
- Time In Range (TIR, %)(Baseline through Week 10)
- Time Above Range (TAR, %)(Baseline through Week 10)
- Postprandial glucose excursion (PPGE) (mmol/L)(Baseline through Week 10)
- Incremental Area Under the Curve (iAUC, mmol/L·min)(Baseline through Week 10)
研究者
Jocelyn Chew
Assistant Professor
National University Health System, Singapore
研究点 (1)
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