Molecular, Metabolomic and Nutritional Changes After Metabolic Surgery

Recruiting

• Conditions: Obesity; Endocrine; Diabete Type 2; PreDiabetes

• Registration Number: NCT05322551
• Lead Sponsor: Ministry of Health, Malaysia

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.

Study Timeline

• Study First Submitted: 2021-12-07
• Study First Submitted QC: 2022-04-03
• Study First Posted: 2022-04-12
• Study Start: 2022-06-24
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-09-01
• Primary Completion: 2023-01
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

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' 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body weight changes	12 months	Body weight changes
Body mass index (BMI) changes	12 months	Body mass index changes measured in kg/m\^2 (weight in kilograms, height in meters)
Fasting Blood Glucose changes	12 months	Fasting Blood Glucose changes measured in mmol/L
HbA1c changes	12 months	HbA1c changes measured in percentage
Changes in lipid related biochemical parameters	12 months	Changes in triglyceride, total cholesterol, LDL cholesterol, HDL cholesterol levels in mmol/L
Body Fat Percentage changes	12 months	Body Fat Percentage changes measured in percentage
Changes of metabolites profile	12 months	Changes of serum diabetes-related metabolites using Nuclear Magnetic Resonance (NMR)

Secondary Outcome Measures

Name	Time	Method
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
Dietary Intake changes	At baseline, month 6 and month 12	Dietary intake changes measured by Food Frequency Questionnaire (FFQ)

Trial Locations

Locations (1)

Institute for Medical Research, National Institutes of Health; 🇲🇾 Shah Alam, Selangor, Malaysia