Comorbidities Resolution After MGB Surgery and Change in Body Composition

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorAll India Institute of Medical Sciences, Bhubaneswar

About this trial

This observational study aims to learn about the correlation between the improving comorbidities associated with obesity after MGB (Mini-Gastric Bypass) surgery and changes in body composition in morbidly obese patients. The main questions it aims to answer are:

To study the correlation between the improving comorbidities associated with obesity after MGB(Mini-Gastric Bypass) surgery and changes in body composition.

Other objectives are:

* Changes in the parameters of the metabolic syndrome after surgery * Changes in the cardiovascular risk biomarkers after metabolic surgery * Emergence in complications arising out of surgery requiring any intervention or causing a prolonged hospital stay, or requiring additional outpatient visits.

Type of Study: An observational study in which participants with morbid obesity will undergo mini-gastric bypass surgery as per routine protocol. No separate experimental interventions will be done in the study for the participants.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients undergoing laparoscopic MGB surgery for morbid obesity and it's associated comorbidities

Disqualifiers

Patients not giving consent for the study

All patients who were undergoing a redo-procedure for recurrence were excluded from the study

Trial population

Patients suffering from morbid obesity and its associated comorbidities like type 2 diabetes, hypertension, obstructive sleep apnea, hypothyroidism, dyslipidemia and chronic venous hypertension of the legs with its complications.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Mini gastric bypass surgery

    Procedure/Surgery

    Mini gastric bypass surgery is a common metabolic or bariatric surgery done world wide for patients suffering from morbid obesity not managed by non surgical modalities of treatment.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Patients with morbid obesity undergoing metabolic surgery (Mini gastric bypass)1 intervention

Trial outcomes

Primary outcomes

1

To study the correlation between the improving comorbidities associated with obesity after MGB(Mini-Gastric Bypass) surgery and changes in body composition.

The comorbidities associated with obesity like type2 diabetes, sleep apnea, dyslipidemia, hypothyroidism and other components of metabolic syndrome improves way ahead after the metabolic surgery as compared to an expected change in the body composition. This study will bring out the correlation between the change in body composition and the morbidity resolution.

Time frame
3 years

Secondary outcomes

1

Changes in the parameters of the metabolic syndrome after surgery

Components of the metabolic syndrome improve after metabolic surgery after different timelines. This study will bring out the time line of resolution of comorbidities after a metabolic surgery.

Time frame
3 years
2

Changes in the cardiovascular risk biomarkers after metabolic surgery

Cardiovascular biomarkers like C reactive proteins (CRP) is stated to improve over time after a metabolic surgery. This study will find out the improvement in the CVS biomarker after the metabolic surgery.

Time frame
3 years
3

Emergence in complications arising out of surgery requiring any intervention or causing a prolonged hospital stay, or requiring additional outpatient visits

The mini gastric bypass surgery done for morbid obesity is a malabsorption procedure done in patients suffering from morbid obesity. Expected changes in the post-operative patients are protein-energy malnutrition, essential vitamins like B12, D, etc, and mineral deficiency may occur. So a follow up of the patients in the post operative period will reveal any postoperative nutritional changes and there consequences.

Time frame
3 years

Other outcomes

Sponsors and contacts

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