Molecular, Metabolomic and Nutritional Changes After Metabolic Surgery (MoMen)

August 29, 2022 updated by: Fazliana Mansor, Ministry of Health, Malaysia

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Malaysia
    • Selangor
      • Shah Alam, Selangor, Malaysia, 40170
        • Recruiting
        • Institute for Medical Research, National Institutes of Health
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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)
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)
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Body weight changes
Time Frame: 6 months
Body weight changes
6 months
Body weight changes
Time Frame: 12 months
Body weight changes
12 months
Body mass index (BMI) changes
Time Frame: 6 months
Body mass index changes measured in kg/m^2 (weight in kilograms, height in meters)
6 months
Body mass index (BMI) changes
Time Frame: 12 months
Body mass index changes measured in kg/m^2 (weight in kilograms, height in meters)
12 months
Body Fat Percentage changes
Time Frame: 6 months
Body Fat Percentage changes measured in percentage
6 months
Body Fat Percentage changes
Time Frame: 12 months
Body Fat Percentage changes measured in percentage
12 months
Fasting Blood Glucose changes
Time Frame: 6 months
Fasting Blood Glucose changes measured in mmol/L
6 months
Fasting Blood Glucose changes
Time Frame: 12 months
Fasting Blood Glucose changes measured in mmol/L
12 months
HbA1c changes
Time Frame: 6 months
HbA1c changes measured in percentage
6 months
HbA1c changes
Time Frame: 12 months
HbA1c changes measured in percentage
12 months
Changes of metabolites profile
Time Frame: 6 months
Changes of serum diabetes-related metabolites using Nuclear Magnetic Resonance (NMR)
6 months
Changes of metabolites profile
Time Frame: 12 months
Changes of serum diabetes-related metabolites using Nuclear Magnetic Resonance (NMR)
12 months
Changes in lipid related biochemical parameters
Time Frame: 6 months
Changes in triglyceride, total cholesterol, LDL cholesterol, HDL cholesterol levels in mmol/L
6 months
Changes in lipid related biochemical parameters
Time Frame: 12 months
Changes in triglyceride, total cholesterol, LDL cholesterol, HDL cholesterol levels in mmol/L
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of Life changes
Time Frame: At baseline, month 6 and month 12
Quality of Life score measured by Obesity and Weight-Loss Quality of Life (OWLQOL ) questionnaire
At baseline, month 6 and month 12
Dietary Intake changes
Time Frame: At baseline, month 6 and month 12
Dietary intake changes measured by Food Frequency Questionnaire (FFQ)
At baseline, month 6 and month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ministry of Health, Malaysia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universiti Putra Malaysia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fazliana Mansor, PhD, Institute for Medical Research, Setia Alam, Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 24, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NMRR-20-2496-56353

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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