Health Condition 1: E662- Morbid (severe) obesity with alveolar hypoventilation Health Condition 2: null- Obesity and associated comorbidities
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria for first cohort (Group I): a) Adult aged between 18-65 yrs b) BMI 25-29.9 kg/m2 Inclusion Criteria for second cohort (GroupII): a)Adult aged between 18-65 yrs b)Normal adult BMI >29.9 kg/m2 to 34.9 kg/m2 Inclusion criteria for nonsurgical intervention in morbidly obese group: a)BMI >=35 kg/m2 b)Adult aged between 18-65 yrs Inclusion criteria for surgical intervention in morbidly obese group: a)Adult aged between 18-65 yrs b)BMI >=35 kg/m2 with co-morbidities or BMI >=40 kg/m2 c)All non surgical measures have been tried but have failed to achieve or maintain adequate, clinically beneficial weight loss for at least 6 month d)Patient with no psychological or clinical contraindications to anesthesia or surgery e)Patient who have comprehension and commitment to long term follow up
Exclusion criteria
Exclusion criteria: Exclusion Criteria for first cohort (Group I): 1)Age below 18 yrs and above 65yrs 2)BMI >29.9kg/m2 3)Pregnant or lactating mothers 4)Acute or severe chronic illness or severe end organ damage 5)Patient is on some drug/s which can lead to hyperglycemia 6)Secondary cause of obesity: any endocrinological dysfunction, drug intake 7)Patient who refuse consent for the study Exclusion Criteria for second cohort (Group II) 1)Age below 18 yrs and above 65yrs 2)BMI >=35kg/m2 3)Pregnant or lactating mothers 4)Acute or severe chronic illness or severe end organ damage 5)Patient is on some drug/s which can lead hyperglycemia 6)Secondary cause of obesity: any endocrinological dysfunction, drug intake 7)Patient who refuse consent for the study Exclusion criteria for nonsurgical intervention in morbidly obese group: 1)BMI 2)Age below 18 yrs and above 65yrs 3)Pregnant or lactating mothers 4)Acute or severe chronic illness or severe end organ damage 5)Patient is on some drug/s which can lead hyperglycemia 6)Secondary cause of obesity: any endocrinological dysfunction, drug intake 7)Patient who refuse consent for the study Exclusion criteria for surgical intervention for morbidly obese group: 1)Age below 18 yrs and above 65yrs 2)BMI >=35 kg/m2 without co-morbidities or BMI 3)Pregnant or lactating mothers 4)Young female patients who have plan to extend family in next 2 years 5)Acute or severe chronic illness or severe end organ damage 6)Patient is on some drug/s which can lead hyperglycemia 7)Secondary cause of obesity: any endocrinological dysfunction, drug intake 8)Patient who are high risk for surgery 9)Patient who refuse consent for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a.Change in weight,Excess weight, waist circumference and waist to hip ratio b. Quality of life c. Physical activity level d. Chang in behavior by the assessment of eating pattern, alcohol consumption and smoking rate, at 3 month,6 month and 1 year interval e. blood chemistry examination f. Blood pressure: g. Change in FBS, FIL, Thyroid function, LFT, HbA1C, if indicated h.Evaluation of serum iron, folate, and vitamin B12 levelin all morbidly obese patient as their routine test Timepoint: a.Change in weight,Excess weight, waist circumference and waist to hip ratio b. Quality of life c. Physical activity level d. Chang in behavior by the assessment of eating pattern, alcohol consumption and smoking rate, at 3 month,6 month and 1 year interval e. blood chemistry examination f. Blood pressure: g. Change in FBS, FIL, Thyroid function, LFT, HbA1C, if indicated h.Evaluation of serum iron, folate, and vitamin B12 levelin all morbidly obese patient as their routine test | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)To assess the impact of intervention on Quality of life and psycho-social functioning in all the groups of patients 2) To assess the impact of intervention on parameters of metabolic syndrome in all the groups of patients Timepoint: Baseline, 3 month,6month, 1 year | — |
Countries
India
Contacts
AIIMS