Molecular, Metabolomic and Nutritional Changes After Metabolic Surgery

NCT ID: NCT05322551

Last Updated: 2022-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 102 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-24
• Study Completion Date: 2024-12-31

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.

Conditions

Obesity; Endocrine; Diabete Type 2; PreDiabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Obese only

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)

No interventions assigned to this group

Obese with prediabetes

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)

No interventions assigned to this group

Obese with diabetes

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).

No interventions assigned to this group

Eligibility Criteria

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

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universiti Putra Malaysia

OTHER

Sponsor Role: collaborator

Ministry of Health, Malaysia

OTHER_GOV

Sponsor Role: lead

Responsible Party

Fazliana Mansor

Research Officer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fazliana Mansor, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute for Medical Research, Setia Alam, Malaysia

Locations

Institute for Medical Research, National Institutes of Health

Shah Alam, Selangor, Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

Fazliana Mansor, PhD

Role: CONTACT

fazliana.m@moh.gov.my

+60162280081

Facility Contacts

Fazliana Mansor, PhD

Role: primary

nanamansor@yahoo.com

0162280081

Other Identifiers

NMRR-20-2496-56353

Identifier Type: -

Identifier Source: org_study_id