An observational study in Obesity, Morbid, Obesity; Endocrine and Fat Disorder, sponsored by All India Institute of Medical Sciences, Bhubaneswar. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by All India Institute of Medical Sciences, Bhubaneswar · Observational
PRIMARY OBJECTIVE To evaluate the changes in body composition in morbid obese patients following bariatric and metabolic surgery
Secondary Objectives:
In this study, morbidly obese patients undergoing bariatric surgery will be assessed at baseline and followed by 3rd and 6 months to evaluate various physiological and biochemical changes
Anthropometric Measurements:
Height (Ht) - measured using a stadiometer Weight (Wt) - measured using a digital weighing scale Body Mass Index (BMI) - calculated as Weight/(Height)2. Kg/m² Waist-Hip Ratio (WHR) - using a measuring tape to assess fat distribution
Basal Metabolic Rate (BMR):
Measured using BIA, Resting energy expenditure will be measured using an indirect colorimeter if feasible.
Muscle Function Assessment:
Muscle Strength: Upper limbs muscle strength will be assessed by using Hand held dynamometer, which will measure hand grip strength(HGS).Three readings will be taken at an interval of 1 minute of rest. The average of 3 readings will be taken as HGS for each arm.A value of less than 28 in men and less than 18 in women will be considered as low HGS(6).
Muscle Performance:
A 6 meter walk test is a reliable test to assess muscle function or physical performance. A gait speed of less than 1 metre/second will be considered as reduced physical performance
Inflammatory Markers:
Interleukin 6 (IL 6) High sensitivity C reactive protein (Hs CRP) Erythrocyte Sedimentation Rate (ESR)
In this study, a comprehensive panel of metabolic and biochemical parameters will be assessed to evaluate the systemic effects of bariatric surgery. Glycemic control will be monitored through FBS, PPBS and HbA1c. Thyroid function will be evaluated by measuring thyroid stimulating hormone (TSH). Renal function will be assessed using serum urea and creatinine levels, urine ACR, while liver function will be evaluated through total bilirubin, AST, ALT, ALP estimation. Lipid metabolism will be examined by measuring total cholesterol, triglycerides, LDLand HDL. Additionally, serum calcium, VitD3 will be included to monitor bone and mineral metabolism, which may be affected by significant weight loss or changes in nutritional status postoperatively. These parameters will provide a holistic view of the physiological changes and health improvements resulting from bariatric surgery.
Follow-up: 3 and 6 months postoperative
Statistical analysis plan:
Data will be managed in Microsoft Excel and analysed using SPSS version 26. Numerical data like BMR, fat mass, etc., will be shown as mean ± SD or median with range.Categorical values like gender and type of surgery will be expressed as percentages.Kolmogorov-Smirnov test will be used to check for normality of continuous variables.Depending on data type, either parametric or non-parametric tests will be applied. All final outcomes will be shown with 95% confidence intervals.A p-value of \<0.05 will be kept as a significant threshold.
941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.
This study's planned enrollment of 21 is below the median of 80 across 311 observational studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →All India Institute of Medical Sciences, Bhubaneswar is the lead sponsor of 59 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Morbidly obese patients undergoing bariatric / Metabolic surgery
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Change in Percentage Body Fat
Percentage body fat will be measured using Bioelectrical Impedance Analysis (BIA).
Time frame: Baseline, 3 months, and 6 months
Change in Skeletal Muscle Mass (kg)
Skeletal Muscle Index will be calculated as appendicular skeletal muscle mass divided by height squared.
Time frame: Baseline, 3 months, and 6 months
Change in Hand Grip Strength
Hand grip strength will be measured using a calibrated hand dynamometer.
Time frame: Baseline, 3 months, and 6 months
No study locations are listed for this record.
Start is estimated for Sep 2026; primary completion for Jun 2027, 9 months later.
Of 137 non-industry observational studies under Obesity, Morbid, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 132. This study's planned 9 months is below that.
Counting every sponsor, half of 138 studies reached it within 46 months; a quarter within 16 and three quarters within 132.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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All India Institute of Medical Sciences, Bhubaneswar