An observational study in Obesity; Endocrine, Diabete Type 2 and PreDiabetes, sponsored by Ministry of Health, Malaysia. Status unknown at 1 site in Malaysia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-01.
Sponsored by Ministry of Health, Malaysia · Observational
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.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 102 is below the median of 114 across 2,154 observational studies indexed under Obesity.
Browse Obesity studies →Ministry of Health, Malaysia is the lead sponsor of 27 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
All subjects with obesity (Body Mass Index ≥ 30kg/m2 [WHO classification])) and diagnosed with pre-diabetes, T2D and non-diabetic (healthy) who are undergoing metabolic surgery at Hospital Kuala Lumpur will be recruited. Healthy individuals will be recruited as controls for reference range
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients' Inclusion Criteria
Healthy individuals' Inclusion Criteria
Exclusion Criteria:
Patients' Exclusion Criteria
Healthy Individuals' Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Definition of Obese: Body Mass Index ≥ 30kg/m\^2 (WHO classification) Definition of Non Diabetes: Fasting Plasma Glucose (FPG) \< FPG 100 mg/dL (5.6 mmol/L)
Definition of Obese: Body Mass Index ≥ 30kg/m\^2 (WHO classification) Definition of Prediabetes: FPG 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) (IFG) OR A1C 5.7-6.4% (39-47 mmol/mol)
Definition of Obese: Body Mass Index ≥ 30kg/m\^2 (WHO classification) Definition of Diabetes: (American Diabetes Association, 2020) FPG ≥126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 h.\* OR A1C ≥6.5% (48 mmol/mol).
Body weight changes
Body weight changes
Time frame: 6 months
Body weight changes
Body weight changes
Time frame: 12 months
Body mass index (BMI) changes
Body mass index changes measured in kg/m\^2 (weight in kilograms, height in meters)
Time frame: 6 months
Body mass index (BMI) changes
Body mass index changes measured in kg/m\^2 (weight in kilograms, height in meters)
Time frame: 12 months
Body Fat Percentage changes
Body Fat Percentage changes measured in percentage
Time frame: 6 months
Body Fat Percentage changes
Body Fat Percentage changes measured in percentage
Time frame: 12 months
Fasting Blood Glucose changes
Fasting Blood Glucose changes measured in mmol/L
Time frame: 6 months
Fasting Blood Glucose changes
Fasting Blood Glucose changes measured in mmol/L
Time frame: 12 months
HbA1c changes
HbA1c changes measured in percentage
Time frame: 6 months
HbA1c changes
HbA1c changes measured in percentage
Time frame: 12 months
Changes of metabolites profile
Changes of serum diabetes-related metabolites using Nuclear Magnetic Resonance (NMR)
Time frame: 6 months
Changes of metabolites profile
Changes of serum diabetes-related metabolites using Nuclear Magnetic Resonance (NMR)
Time frame: 12 months
Changes in lipid related biochemical parameters
Changes in triglyceride, total cholesterol, LDL cholesterol, HDL cholesterol levels in mmol/L
Time frame: 6 months
Changes in lipid related biochemical parameters
Changes in triglyceride, total cholesterol, LDL cholesterol, HDL cholesterol levels in mmol/L
Time frame: 12 months
Quality of Life changes
Quality of Life score measured by Obesity and Weight-Loss Quality of Life (OWLQOL ) questionnaire
Time frame: At baseline, month 6 and month 12
Dietary Intake changes
Dietary intake changes measured by Food Frequency Questionnaire (FFQ)
Time frame: At baseline, month 6 and month 12
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Ministry of Health, Malaysia