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NCT Number: NCT06015620

Comorbidities Resolution After MGB Surgery and Change in Body Composition

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.

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Key information

Conditions

Morbid Obesity Apnea Body Weight Cardiovascular Diseases Chronic Venous Hypertension With Ulcer Digestive System Diseases Dyssomnias Endocrine System Diseases Fatty Liver Glucose Metabolism Disorders Hyperinsulinism Hypertension Hypothyroidism Insulin Resistance Lipid Disorder Lipid Metabolism Disorders Liver Diseases Metabolic Diseases Metabolic Syndrome Nervous System Diseases Non-Alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Thyroid Diseases Type2diabetes Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mini gastric bypass surgery

Procedure

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.

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.

    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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Prakash K Sasmal, MS, FACS

CONTACT

[email protected]

+91 9438884255

Velugoti Sai Pradeep, MBBS

CONTACT

[email protected]

+91 6300465988

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences, Bhubaneswar

Other

Registry information

Official study title

CoMOrbidities Resolution After Mini-GAstric Bypass Surgery for Morbid Obesity and Change in BOdy Composition: A Prospective Cohort Study (MOGAMBO Study)

Acronym: MOGAMBO

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Aug 29, 2023
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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