Diabete Type 2, Obesity; Endocrine, PreDiabetes
Conditions
Keywords
Bariatric surgery, Metabolic surgery
Brief summary
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.
Detailed description
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. Metabolic surgery The two most standard metabolic surgical procedures performed at Hospital Kuala Lumpur are laparoscopic sleeve gastrectomy and laparoscopic Roux en Y gastric bypass (RYGB). All the procedures are performed laparoscopically using 5-ports technique.
Interventions
None listed
Sponsors
Universiti Putra Malaysia
Ministry of Health, Malaysia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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)
Exclusion criteria
Patients'
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in lipid related biochemical parameters | 6 months | Changes in triglyceride, total cholesterol, LDL cholesterol, HDL cholesterol levels in mmol/L |
| HbA1c changes | 6 months | HbA1c changes measured in percentage |
| Changes of metabolites profile | 6 months | Changes of serum diabetes-related metabolites using Nuclear Magnetic Resonance (NMR) |
| Body weight changes | 6 months | Body weight changes |
| Body mass index (BMI) changes | 6 months | Body mass index changes measured in kg/m\^2 (weight in kilograms, height in meters) |
| Body Fat Percentage changes | 6 months | Body Fat Percentage changes measured in percentage |
| Fasting Blood Glucose changes | 6 months | Fasting Blood Glucose changes measured in mmol/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dietary Intake changes | At baseline, month 6 and month 12 | Dietary intake changes measured by Food Frequency Questionnaire (FFQ) |
| Quality of Life changes | At baseline, month 6 and month 12 | Quality of Life score measured by Obesity and Weight-Loss Quality of Life (OWLQOL ) questionnaire |
Countries
Malaysia
Contacts
Primary ContactFazliana Mansor, PhD
Outcome results
None listed