Molecular, Metabolomic and Nutritional Changes After Metabolic Surgery

PreDiabetes Clinical Trial

— MoMen  

Official title:

Molecular, Metabolomic and Nutritional Changes After Metabolic Surgery Among Obese Diabetic Patients and Biomarkers of Different Diabetes Status.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05322551
• Other study ID #: NMRR-20-2496-56353
• Status: Recruiting
• Start date: June 24, 2022
• Est. completion date: December 2024

Study information

• Verified date: August 2022
• Source: Ministry of Health, Malaysia
• Contact: Fazliana Mansor, PhD
• Phone: +60162280081
• Email: fazliana.m[@]moh.gov.my
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: December 2024
• Est. primary completion date: January 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabete Type 2
• Diabetes Mellitus, Type 2
• Obesity; Endocrine
• PreDiabetes
• Prediabetic State

Locations

Country	Name	City	State
Malaysia	Institute for Medical Research, National Institutes of Health	Shah Alam	Selangor

Sponsors (2)

Lead Sponsor	Collaborator
Ministry of Health, Malaysia	Universiti Putra Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight changes	Body weight changes	6 months
Primary	Body weight changes	Body weight changes	12 months
Primary	Body mass index (BMI) changes	Body mass index changes measured in kg/m^2 (weight in kilograms, height in meters)	6 months
Primary	Body mass index (BMI) changes	Body mass index changes measured in kg/m^2 (weight in kilograms, height in meters)	12 months
Primary	Body Fat Percentage changes	Body Fat Percentage changes measured in percentage	6 months
Primary	Body Fat Percentage changes	Body Fat Percentage changes measured in percentage	12 months
Primary	Fasting Blood Glucose changes	Fasting Blood Glucose changes measured in mmol/L	6 months
Primary	Fasting Blood Glucose changes	Fasting Blood Glucose changes measured in mmol/L	12 months
Primary	HbA1c changes	HbA1c changes measured in percentage	6 months
Primary	HbA1c changes	HbA1c changes measured in percentage	12 months
Primary	Changes of metabolites profile	Changes of serum diabetes-related metabolites using Nuclear Magnetic Resonance (NMR)	6 months
Primary	Changes of metabolites profile	Changes of serum diabetes-related metabolites using Nuclear Magnetic Resonance (NMR)	12 months
Primary	Changes in lipid related biochemical parameters	Changes in triglyceride, total cholesterol, LDL cholesterol, HDL cholesterol levels in mmol/L	6 months
Primary	Changes in lipid related biochemical parameters	Changes in triglyceride, total cholesterol, LDL cholesterol, HDL cholesterol levels in mmol/L	12 months
Secondary	Quality of Life changes	Quality of Life score measured by Obesity and Weight-Loss Quality of Life (OWLQOL ) questionnaire	At baseline, month 6 and month 12
Secondary	Dietary Intake changes	Dietary intake changes measured by Food Frequency Questionnaire (FFQ)	At baseline, month 6 and month 12