Comorbidities Resolution After MGB Surgery and Change in Body Composition

NCT ID: NCT06015620

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2026-09-30

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.

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; Non-Alcoholic Fatty Liver Disease; Chronic Venous Hypertension With Ulcer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

All India Institute of Medical Sciences, Bhubaneswar

OTHER

Sponsor Role: lead

Responsible Party

Dr. Prakash Kumar Sasmal

Additional Professor of General Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prakash K Sasmal, MS, FACS

Role: PRINCIPAL_INVESTIGATOR

All India Institute of Medical Sciences, Bhubaneswar, India

Locations

All India Institute of Medical Sciences

Bhubaneswar, Odisha, India

Site Status: RECRUITING

Countries

India

Central Contacts

Prakash K Sasmal, MS, FACS

Role: CONTACT

drpksasmal@gmail.com

+91 9438884255

Velugoti Sai Pradeep, MBBS

Role: CONTACT

saiprad372@gmail.com

+91 6300465988

Facility Contacts

Prof. Prakash Kumar Sasmal, MS, FNB (MAS), FACS

Role: primary

drpksasmal@gmail.com

+91 9438884255

Dr Velugoti Sai Pradeep, MBBS

Role: backup

saiprad372@gmail.com

+91 6300465988

References

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.

Reference Type: BACKGROUND

PMID: 30049595 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30001381 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23856989 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17728530 (View on PubMed)

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.

Reference Type: RESULT

PMID: 33715992 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35159232 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30020323 (View on PubMed)

Other Identifiers

AIIMSBBSR/PGThesis/2023-24/61

Identifier Type: -

Identifier Source: org_study_id