Comorbidities Resolution After MGB Surgery and Change in Body Composition

NCT06015620 | Recruiting DMC

• 1 other identifier: AIIMSBBSR/PGThesis/2023-24/61
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity; Type2diabetes; Sleep Apnea; Hypothyroidism; Hypertension; Lipid Disorder; Non-Alcoholic Fatty Liver Disease; Chronic Venous Hypertension With Ulcer

Keywords

morbid obesity; OSA; mini gastric bypass; metabolic surgery; polysomnography; metabolic syndrome; DEXA scan; bioelectrical impedance; body composition

Outcome Measures

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.

  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 Outcomes (3)

• Changes in the parameters of the metabolic syndrome after surgery

  3 years

• Changes in the cardiovascular risk biomarkers after 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

  3 years

Study Arms (1)

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

Interventions

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.

Patients with morbid obesity undergoing metabolic surgery (Mini gastric bypass)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients not giving consent for the study
• All patients who were undergoing a redo-procedure for recurrence were excluded from the study

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

Study Sites (1)

All India Institute of Medical Sciences

Bhubaneswar, Odisha, 751019, India

RECRUITING

Related Publications (7)

• 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.

  PMID: 30049595 BACKGROUND

• 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.

  PMID: 30001381 RESULT

• 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.

  PMID: 23856989 RESULT

• 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.

  PMID: 17728530 RESULT

• 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.

  PMID: 33715992 RESULT

• 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.

  PMID: 35159232 RESULT

• 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.

  PMID: 30020323 RESULT

MeSH Terms

Conditions

Obesity, Morbid; Sleep Apnea Syndromes; Hypothyroidism; Hypertension; Lipid Metabolism Disorders; Non-alcoholic Fatty Liver Disease; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Thyroid Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders

Study Officials

• Prakash K Sasmal, MS, FACS

  All India Institute of Medical Sciences, Bhubaneswar, India

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prakash K Sasmal, MS, FACS

CONTACT

+91 9438884255; drpksasmal@gmail.com

Velugoti Sai Pradeep, MBBS

CONTACT

+91 6300465988; saiprad372@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor of General Surgery

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 29, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)