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Comorbidities Resolution After MGB Surgery and Change in Body Composition (MOGAMBO)

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ClinicalTrials.gov Identifier: NCT06015620
Recruitment Status : Recruiting
First Posted : August 29, 2023
Last Update Posted : February 21, 2024
Sponsor:
Information provided by (Responsible Party):
Dr. Prakash Kumar Sasmal, All India Institute of Medical Sciences, Bhubaneswar

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.


Condition or disease Intervention/treatment
Morbid Obesity Type2diabetes Sleep Apnea Hypothyroidism Hypertension Lipid Disorder Non-Alcoholic Fatty Liver Disease Chronic Venous Hypertension With Ulcer Procedure: Mini gastric bypass surgery

Detailed Description:
Evidence supports that bariatric or metabolic surgery is more effective than conventional therapy in controlling obesity and its related comorbidities. Although bariatric surgery has been widely practised for many years worldwide, there is still a need to understand the correlation between improving comorbidities associated with morbid obesity and body composition change post-surgery. Amongst the comorbidities, type II diabetes, sleep apnea, hypertension, and hypothyroidism are the significant ones associated with morbid obesity. A disturbed quality of sleep results in daytime sleepiness, cardiac problems, renal problems, etc., which in turn grossly reduces the work efficiency of an individual and increases morbidity and mortality. From our experience, after a metabolic surgery (mini-gastric bypass -MGB), the investigators find comorbidities, especially sleep apnoea and type II diabetes, getting controlled early before significant weight loss has started. Also, there is an improvement in the parameters of the metabolic syndrome after metabolic surgery. The prospective cohort study aims to correlate the comorbidities resolution after mini-gastric bypass surgery for morbid obesity and change in body composition.
Study Design
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Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CoMOrbidities Resolution After Mini-GAstric Bypass Surgery for Morbid Obesity and Change in BOdy Composition: A Prospective Cohort Study (MOGAMBO Study)
Actual Study Start Date : September 1, 2023
Estimated Primary Completion Date : August 31, 2025
Estimated Study Completion Date : September 30, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with morbid obesity undergoing metabolic surgery (Mini gastric bypass)
The patients undergoing mini gastric bypass surgery for morbid obesity and its different comorbidities like type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea, hypothyroidism and chronic venous hypertension.
 Procedure: Mini gastric bypass 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.


Outcome Measures
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Primary Outcome Measures :
  1. To study the correlation between the improving comorbidities associated with obesity after MGB(Mini-Gastric Bypass) surgery and changes in body composition. [ Time Frame: 3 years ]
    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.


Secondary Outcome Measures :
  1. Changes in the parameters of the metabolic syndrome after surgery [ Time Frame: 3 years ]
    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.

  2. Changes in the cardiovascular risk biomarkers after metabolic surgery [ Time Frame: 3 years ]
    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.

  3. Emergence in complications arising out of surgery requiring any intervention or causing a prolonged hospital stay, or requiring additional outpatient visits [ Time Frame: 3 years ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study 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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients not giving consent for the study
  • All patients who were undergoing a redo-procedure for recurrence were excluded from the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06015620


Contacts
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Contact: Prakash K Sasmal, MS, FACS +91 9438884255 drpksasmal@gmail.com
Contact: Velugoti Sai Pradeep, MBBS +91 6300465988 saiprad372@gmail.com

Locations
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India
All India Institute of Medical Sciences Recruiting
Bhubaneswar, Odisha, India, 751019
Contact: Prof. Prakash Kumar Sasmal, MS, FNB (MAS), FACS    +91 9438884255    drpksasmal@gmail.com   
Contact: Dr Velugoti Sai Pradeep, MBBS    +91 6300465988    saiprad372@gmail.com   
Sponsors and Collaborators
All India Institute of Medical Sciences, Bhubaneswar
Investigators
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Principal Investigator: Prakash K Sasmal, MS, FACS All India Institute of Medical Sciences, Bhubaneswar, India
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Dr. Prakash Kumar Sasmal, Additional Professor of General Surgery, All India Institute of Medical Sciences, Bhubaneswar
ClinicalTrials.gov Identifier: NCT06015620    
Other Study ID Numbers: AIIMSBBSR/PGThesis/2023-24/61
First Posted: August 29, 2023    Key Record Dates
Last Update Posted: February 21, 2024
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only the result of the study will be provided at the end. No individual patients detail will be revealed. However, the statistical analysis details, including the study protocol can be shared if required by any researcher.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Prakash Kumar Sasmal, All India Institute of Medical Sciences, Bhubaneswar:
morbid obesity
OSA
mini gastric bypass
metabolic surgery
polysomnography
 metabolic syndrome
DEXA scan
bioelectrical impedance
body composition
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Hypertension
Obesity
Obesity, Morbid
Lipid Metabolism Disorders
Hypothyroidism
Overweight
 Overnutrition
Nutrition Disorders
Body Weight
Vascular Diseases
Cardiovascular Diseases
Digestive System Diseases
Thyroid Diseases
Endocrine System Diseases
Metabolic Diseases