Obesity; EndocrineMoMenNCT05322551
Molecular, Metabolomic and Nutritional Changes After Metabolic Surgery
An observational study of Obesity; Endocrine and Diabete Type 2, run by Ministry of Health, Malaysia at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity; Endocrine, Diabete Type 2, PreDiabetes
- How many people
- 102 participants
- Where
- 1 siteMalaysia
- Study dates
- 24 Jun 2022to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Show all 13Show fewer
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Institute for Medical Research, National Institutes of Health
Shah Alam, Selangor, 40170
Fazliana Mansor, PhD, 0162280081, nanamansor@yahoo.com
About this study
Official title: 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.
Read the 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
- Keywords
- Bariatric surgery, Metabolic surgery
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Body weight changes
Body weight changes
Measured: 6 months
Body weight changes
Body weight changes
Measured: 12 months
Body mass index (BMI) changes
Body mass index changes measured in kg/m^2 (weight in kilograms, height in meters)
Measured: 6 months
Body mass index (BMI) changes
Body mass index changes measured in kg/m^2 (weight in kilograms, height in meters)
Measured: 12 months
Body Fat Percentage changes
Body Fat Percentage changes measured in percentage
Measured: 6 months
Body Fat Percentage changes
Body Fat Percentage changes measured in percentage
Measured: 12 months
Fasting Blood Glucose changes
Fasting Blood Glucose changes measured in mmol/L
Measured: 6 months
Fasting Blood Glucose changes
Fasting Blood Glucose changes measured in mmol/L
Measured: 12 months
HbA1c changes
HbA1c changes measured in percentage
Measured: 6 months
HbA1c changes
HbA1c changes measured in percentage
Measured: 12 months
Changes of metabolites profile
Changes of serum diabetes-related metabolites using Nuclear Magnetic Resonance (NMR)
Measured: 6 months
Changes of metabolites profile
Changes of serum diabetes-related metabolites using Nuclear Magnetic Resonance (NMR)
Measured: 12 months
Changes in lipid related biochemical parameters
Changes in triglyceride, total cholesterol, LDL cholesterol, HDL cholesterol levels in mmol/L
Measured: 6 months
Changes in lipid related biochemical parameters
Changes in triglyceride, total cholesterol, LDL cholesterol, HDL cholesterol levels in mmol/L
Measured: 12 months
Secondary outcomes (2)
Quality of Life changes
Quality of Life score measured by Obesity and Weight-Loss Quality of Life (OWLQOL ) questionnaire
Measured: At baseline, month 6 and month 12
Dietary Intake changes
Dietary intake changes measured by Food Frequency Questionnaire (FFQ)
Measured: At baseline, month 6 and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start24 Jun 2022
- Primary completionJan 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity; EndocrineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Malaysia
- Sponsor type
- Other government
- Collaborators
- Universiti Putra Malaysia
- Responsible party
- Principal investigator, Fazliana Mansor, Ministry of Health, Malaysia
- Investigators
- Fazliana Mansor, PhD, Principal investigator, Institute for Medical Research, Setia Alam, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322551
- Sponsor's protocol ID
- NMRR-20-2496-56353
- Acronym
- MoMen
- Status last verified
- Aug 2022
- First submitted
- 7 Dec 2021
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular, Metabolomic and Nutritional Changes After Metabolic Surgery Among Obese Diabetic Patients and Biomarkers of Different Diabetes Status.
- ClinicalTrials.gov ID
- NCT05322551
- Acronym / sponsor ID
- MoMen / NMRR-20-2496-56353
- Conditions
- Obesity; Endocrine, Diabete Type 2, PreDiabetes
- Keywords
- Bariatric surgery, Metabolic surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Ministry of Health, MalaysiaOther government
- Collaborators
- Universiti Putra Malaysia
- Study start
- 24 Jun 2022 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (13 listed)
- Patients' Inclusion Criteria
- BMI > 30kg/m2
- Men and women
- Ages 18-65 years old
- Diabetes status (non diabetic, pre diabetes and diabetes)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body weight changes
Time frame: 6 months
Body weight changes
Body weight changes
Time frame: 12 months
Body weight changes
Body mass index (BMI) changes
Time frame: 6 months
Body mass index changes measured in kg/m^2 (weight in kilograms, height in meters)
Body mass index (BMI) changes
Time frame: 12 months
Body mass index changes measured in kg/m^2 (weight in kilograms, height in meters)
Body Fat Percentage changes
Time frame: 6 months
Body Fat Percentage changes measured in percentage
Body Fat Percentage changes
Time frame: 12 months
Body Fat Percentage changes measured in percentage
Fasting Blood Glucose changes
Time frame: 6 months
Fasting Blood Glucose changes measured in mmol/L
Fasting Blood Glucose changes
Time frame: 12 months
Fasting Blood Glucose changes measured in mmol/L
HbA1c changes
Time frame: 6 months
HbA1c changes measured in percentage
HbA1c changes
Time frame: 12 months
HbA1c changes measured in percentage
Changes of metabolites profile
Time frame: 6 months
Changes of serum diabetes-related metabolites using Nuclear Magnetic Resonance (NMR)
Changes of metabolites profile
Time frame: 12 months
Changes of serum diabetes-related metabolites using Nuclear Magnetic Resonance (NMR)
Changes in lipid related biochemical parameters
Time frame: 6 months
Changes in triglyceride, total cholesterol, LDL cholesterol, HDL cholesterol levels in mmol/L
Changes in lipid related biochemical parameters
Time frame: 12 months
Changes in triglyceride, total cholesterol, LDL cholesterol, HDL cholesterol levels in mmol/L
2 secondary outcomes
Quality of Life changes
Time frame: At baseline, month 6 and month 12
Dietary Intake changes
Time frame: At baseline, month 6 and month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fazliana Mansor, PhD principal investigator
Institute for Medical Research, Setia Alam, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity; Endocrine and Diabete Type 2, run by Ministry of Health, Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fazliana Mansor, PhD (+60162280081, fazliana.m@moh.gov.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight changes (time frame: 6 months). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.