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

  • STATUS
    Recruiting
  • End date
    Dec 20, 2024
  • participants needed
    102
  • sponsor
    Ministry of Health, Malaysia
Updated on 7 October 2022
hypertension
Accepts healthy volunteers

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.

Details
Condition Obesity; Endocrine, Diabete Type 2, PreDiabetes
Clinical Study IdentifierNCT05322551
SponsorMinistry of Health, Malaysia
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note