- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06015620
Comorbidities Resolution After MGB Surgery and Change in Body Composition (MOGAMBO)
CoMOrbidities Resolution After Mini-GAstric Bypass Surgery for Morbid Obesity and Change in BOdy Composition: A Prospective Cohort Study (MOGAMBO Study)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Prakash K Sasmal, MS, FACS
- Phone Number: +91 9438884255
- Email: drpksasmal@gmail.com
Study Contact Backup
- Name: Velugoti Sai Pradeep, MBBS
- Phone Number: +91 6300465988
- Email: saiprad372@gmail.com
Study Locations
-
-
Odisha
-
Bhubaneswar, Odisha, India, 751019
- Recruiting
- All India Institute of Medical Sciences
-
Contact:
- Prof. Prakash Kumar Sasmal, MS, FNB (MAS), FACS
- Phone Number: +91 9438884255
- Email: drpksasmal@gmail.com
-
Contact:
- Dr Velugoti Sai Pradeep, MBBS
- Phone Number: +91 6300465988
- Email: saiprad372@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 years
|
|
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 years
|
|
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.
|
3 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Prakash K Sasmal, MS, FACS, All India Institute of Medical Sciences, Bhubaneswar, India
Publications and helpful links
General Publications
- Rudnicki Y, Slavin M, Keidar A, Kent I, Berkovich L, Tiomkin V, Inbar R, Avital S. The effect of bariatric surgery on hypothyroidism: Sleeve gastrectomy versus gastric bypass. Surg Obes Relat Dis. 2018 Sep;14(9):1297-1303. doi: 10.1016/j.soard.2018.06.008. Epub 2018 Jun 15.
- Achamrah N, Colange G, Delay J, Rimbert A, Folope V, Petit A, Grigioni S, Dechelotte P, Coeffier M. Comparison of body composition assessment by DXA and BIA according to the body mass index: A retrospective study on 3655 measures. PLoS One. 2018 Jul 12;13(7):e0200465. doi: 10.1371/journal.pone.0200465. eCollection 2018.
- Ravesloot MJ, Hilgevoord AA, van Wagensveld BA, de Vries N. Assessment of the effect of bariatric surgery on obstructive sleep apnea at two postoperative intervals. Obes Surg. 2014 Jan;24(1):22-31. doi: 10.1007/s11695-013-1023-y.
- Fritscher LG, Canani S, Mottin CC, Fritscher CC, Berleze D, Chapman K, Chatkin JM. Bariatric surgery in the treatment of obstructive sleep apnea in morbidly obese patients. Respiration. 2007;74(6):647-52. doi: 10.1159/000107736. Epub 2007 Aug 29.
- Cogollo VJ, Rivera CE, Valera RJ, Sarmiento-Cobos M, Montorfano L, Wasser E, Lo Menzo E, Szomstein S, Rosenthal RJ. Improvement of glucose metabolism following rapid weight loss after bariatric surgery and its impact on reduction of visceral abdominal fat versus free fat muscle. Surg Obes Relat Dis. 2021 May;17(5):933-938. doi: 10.1016/j.soard.2021.01.031. Epub 2021 Feb 2.
- Snelder SM, Pouw N, Aga Y, Castro Cabezas M, Biter LU, Zijlstra F, Kardys I, van Dalen BM. Cardiovascular Biomarker Profiles in Obesity and Relation to Normalization of Subclinical Cardiac Dysfunction after Bariatric Surgery. Cells. 2022 Jan 26;11(3):422. doi: 10.3390/cells11030422.
- Castanha CR, Tcbc-Pe AABF, Castanha AR, Belo GQMB, Lacerda RMR, Vilar L. Evaluation of quality of life, weight loss and comorbidities of patients undergoing bariatric surgery. Rev Col Bras Cir. 2018 Jul 16;45(3):e1864. doi: 10.1590/0100-6991e-20181864. English, Portuguese.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Nutrition Disorders
- Metabolic Diseases
- Overnutrition
- Body Weight
- Respiratory Tract Diseases
- Digestive System Diseases
- Respiration Disorders
- Glucose Metabolism Disorders
- Liver Diseases
- Sleep Wake Disorders
- Insulin Resistance
- Hyperinsulinism
- Overweight
- Apnea
- Sleep Disorders, Intrinsic
- Dyssomnias
- Thyroid Diseases
- Obesity
- Fatty Liver
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Hypertension
- Metabolic Syndrome
- Sleep Apnea Syndromes
- Non-alcoholic Fatty Liver Disease
- Obesity, Morbid
- Lipid Metabolism Disorders
- Hypothyroidism
Other Study ID Numbers
- AIIMSBBSR/PGThesis/2023-24/61
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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