Morbid ObesityMOGAMBONCT06015620
Comorbidities Resolution After MGB Surgery and Change in Body Composition
An observational study of Morbid Obesity and Type2diabetes, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity, Type2diabetes, Sleep Apnea
- What is being tested?
- Mini gastric bypass surgery
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteIndia
- Study dates
- 1 Sep 2023to 30 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All patients undergoing laparoscopic MGB surgery for morbid obesity and it's associated comorbidities
Who cannot join
- Patients not giving consent for the study
- All patients who were undergoing a redo-procedure for recurrence were excluded from the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
All India Institute of Medical Sciences
Bhubaneswar, Odisha, 751019
Prof. Prakash Kumar Sasmal, MS, FNB (MAS), FACS, +91 9438884255, drpksasmal@gmail.com
Dr Velugoti Sai Pradeep, MBBS, +91 6300465988, saiprad372@gmail.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Morbid Obesity, Type2diabetes, Sleep Apnea, Hypothyroidism, Hypertension, Lipid Disorder
- Being tested
- Mini gastric bypass surgery
- Keywords
- morbid obesity, OSA, mini gastric bypass, metabolic surgery, polysomnography, metabolic syndrome, DEXA scan, bioelectrical impedance, body composition
- Medical subject headings
- Obesity, Morbid, Sleep Apnea Syndromes, Hypothyroidism, Hypertension, Lipid Metabolism Disorders, Non-alcoholic Fatty Liver Disease, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini gastric bypass surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Mini gastric bypass surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (3)
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.
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Prakash Kumar Sasmal, All India Institute of Medical Sciences, Bhubaneswar
- Investigators
- Prakash K Sasmal, MS, FACS, Principal investigator, All India Institute of Medical Sciences, Bhubaneswar, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015620
- Sponsor's protocol ID
- AIIMSBBSR/PGThesis/2023-24/61
- Acronym
- MOGAMBO
- Status last verified
- Feb 2026
- First submitted
- 22 Aug 2023
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 30049595Achamrah 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.
PubMed 30001381Ravesloot 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.
PubMed 23856989Fritscher 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.
PubMed 17728530Cogollo 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.
PubMed 33715992Snelder 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.
PubMed 35159232Castanha 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.
PubMed 30020323
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CoMOrbidities Resolution After Mini-GAstric Bypass Surgery for Morbid Obesity and Change in BOdy Composition: A Prospective Cohort Study (MOGAMBO Study)
- ClinicalTrials.gov ID
- NCT06015620
- Acronym / sponsor ID
- MOGAMBO / AIIMSBBSR/PGThesis/2023-24/61
- Conditions
- Morbid Obesity, Type2diabetes, Sleep Apnea, Hypothyroidism, Hypertension, Lipid Disorder
- Keywords
- morbid obesity, OSA, mini gastric bypass, metabolic surgery, polysomnography, metabolic syndrome, DEXA scan, bioelectrical impedance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with morbid obesity undergoing metabolic surgery (Mini gastric bypass) | – | Procedure: Mini gastric bypass surgeryThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients undergoing laparoscopic MGB surgery for morbid obesity and it's associated comorbidities
Key exclusion criteria (2 listed)
- Patients not giving consent for the study
- All patients who were undergoing a redo-procedure for recurrence were excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini gastric bypass surgeryMini 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. | Procedure or surgery | Patients with morbid obesity undergoing metabolic surgery (Mini gastric bypass) |
Primary outcome
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 secondary outcomes
Changes in the parameters of the metabolic syndrome after surgery
Time frame: 3 years
Changes in the cardiovascular risk biomarkers after metabolic surgery
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Background: PubMed 30049595Rudnicki 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.
- Results publication: PubMed 30001381Achamrah 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.
- Results publication: PubMed 23856989Ravesloot 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.
- Results publication: PubMed 17728530Fritscher 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.
- Results publication: PubMed 33715992Cogollo 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.
- Results publication: PubMed 35159232Snelder 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.
- Results publication: PubMed 30020323Castanha 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prakash K Sasmal, MS, FACS principal investigator
All India Institute of Medical Sciences, Bhubaneswar, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity and Type2diabetes, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prakash K Sasmal, MS, FACS (+91 9438884255, drpksasmal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06015620, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.