Molecular, Metabolomic and Nutritional Changes After Metabolic Surgery Among Obese Diabetic Patients and Biomarkers of Different Diabetes Status.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Body weight changes
研究概览
简要总结
Obesity is a major risk factor for Type 2 Diabetes (T2D) and cardiovascular diseases, such as hypertension and dyslipidemia. Recently, weight loss surgery (i.e., metabolic or bariatric surgery) has been shown to result in very good long-term glycemic control in patients with T2D and obesity. However, knowledge and data on molecular levels and metabolomics are still limited. This study will fill in these gaps and provide potential biomarkers for T2D. Lifestyle and dietary practices (LDP) influence the clinical outcome and metabolites in T2D. Although the roles of LDP is critical in ensuring optimal clinical outcomes, data is still limited especially on relating the LDP and metabolomics in T2D.
详细描述
Study design
This is a prospective single centre study to explore molecular aspects and metabolomic changes among 102 obese individuals of different diabetes status, undergoing metabolic surgery, which is currently performed in Hospital Kuala Lumpur, Malaysia. Serial measurements of the selected markers will be made pre-operative (baseline), at 6 and 12 months follow up after surgery. Twenty (20) healthy individuals will be recruited as controls.
Study population
All subjects with obesity (Body Mass Index ≥ 30kg/m^2 [WHO classification])) and diagnosed with pre-diabetes, T2D and non-diabetic (healthy) who are undergoing metabolic surgery at Hospital Kuala Lumpur will be recruited.
All patients referred by endocrinologists who are eligible and fulfill the inclusion and exclusion criteria for metabolic surgery will be included in the study until the sample size is achieved. Routinely, all patients will need to pay a visit to the clinic at 1, 2, 4 weeks after surgery, then 3, 6, 9, 12, 18, 24 months and after that, a life-long annual visit. Therefore, visit 6- and 12-month will be utilized for study follow-ups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients' Inclusion Criteria
- •BMI > 30kg/m2
- •Men and women
- •Ages 18-65 years old
- •Diabetes status (non diabetic, pre diabetes and diabetes)
- •Patients who will undergo metabolic surgery
- •Healthy individuals' Inclusion Criteria
- •BMI < 30kg/m2,
- •Men and women
- •Ages 18-65 years old
- •No diabetes
- •No pre diabetes
- •No other co-morbidities (high total cholesterol, high triglycerides, high blood pressure)
排除标准
- •Patients' Exclusion Criteria
- •BMI <30 kg/m2
- •Use of medications that may affect body weight at screening or during a 3 month period prior
- •Other medical conditions like Cushing's, acromegaly, Heart failure, Crohn's disease, etc
- •Alcohol dependence
- •Healthy Individuals' Exclusion Criteria
- •BMI > 30 kg/m2 (obese)
- •BMI < 18.5 kg/m2 (underweight)
- •Diabetes status (pre diabetes and diabetes)
- •Use of medications that may affect body weight at screening or during a 3 month period prior
- •Other co-morbidities (high total cholesterol, high triglycerides, high blood pressure, cancer)
- •Other medical conditions like Cushing's, acromegaly, Heart failure, Crohn's disease, etc
- •Alcohol dependence
结局指标
主要结局
Body weight changes
时间窗: 12 months
Body weight changes
Body mass index (BMI) changes
时间窗: 12 months
Body mass index changes measured in kg/m\^2 (weight in kilograms, height in meters)
Fasting Blood Glucose changes
时间窗: 12 months
Fasting Blood Glucose changes measured in mmol/L
HbA1c changes
时间窗: 12 months
HbA1c changes measured in percentage
Changes in lipid related biochemical parameters
时间窗: 12 months
Changes in triglyceride, total cholesterol, LDL cholesterol, HDL cholesterol levels in mmol/L
Body Fat Percentage changes
时间窗: 12 months
Body Fat Percentage changes measured in percentage
Changes of metabolites profile
时间窗: 12 months
Changes of serum diabetes-related metabolites using Nuclear Magnetic Resonance (NMR)
次要结局
- Quality of Life changes(At baseline, month 6 and month 12)
- Dietary Intake changes(At baseline, month 6 and month 12)
研究者
Fazliana Mansor
Research Officer
Ministry of Health, Malaysia