Shah Faisal MBBS Mentor Joseph A. Caruana MD. Aim and Objective

Shah Faisal MBBS

Mentor

Joseph A. Caruana MD

Aim and Objective

Aim and ObjectiveSome patients after Roux-en-Y Gastric Bypass undergo

“Sub-optimal” Weight Loss (SWL).

Aim and ObjectiveSome patients after Roux-en-Y Gastric Bypass undergo

“Sub-optimal” Weight Loss (SWL).Age, Gender and BMI are the major contributors to

weight loss pattern.

Aim and ObjectiveSome patients after Roux-en-Y Gastric Bypass undergo

“Sub-optimal” Weight Loss (SWL).Age, Gender and BMI are the major contributors to

weight loss pattern.Are there any more subtle and/or modifiable variables

which play a role?

Problem of Obesity

Problem of Obesity Two thirds of individuals living in the US are

overweight, and of those, almost half are obese.

Problem of Obesity Two thirds of individuals living in the US are

overweight, and of those, almost half are obese. DM-2, dyslipidemia, CAD, HTN, OSA are a few of the

myriad complications that obesity predisposes to.

Problem of Obesity Two thirds of individuals living in the US are

overweight, and of those, almost half are obese. DM-2, dyslipidemia, CAD, HTN, OSA are a few of the

myriad complications that obesity predisposes to. Known association with some common cancers:

Problem of Obesity Two thirds of individuals living in the US are

overweight, and of those, almost half are obese. DM-2, dyslipidemia, CAD, HTN, OSA are a few of the

myriad complications that obesity predisposes to. Known association with some common cancers:

Liver, kidney, breast, endometrial, prostate, colon…

Problem of Obesity Two thirds of individuals living in the US are

overweight, and of those, almost half are obese. DM-2, dyslipidemia, CAD, HTN, OSA are a few of the

myriad complications that obesity predisposes to. Known association with some common cancers:

Liver, kidney, breast, endometrial, prostate, colon…Huge burden on healthcare cost:

Problem of Obesity Two thirds of individuals living in the US are

overweight, and of those, almost half are obese. DM-2, dyslipidemia, CAD, HTN, OSA are a few of the

myriad complications that obesity predisposes to. Known association with some common cancers:

Liver, kidney, breast, endometrial, prostate, colon…Huge burden on healthcare cost:

25 % greater among subjects with a BMI 30 to 34.9

Problem of Obesity Two thirds of individuals living in the US are

overweight, and of those, almost half are obese. DM-2, dyslipidemia, CAD, HTN, OSA are a few of the

myriad complications that obesity predisposes to. Known association with some common cancers.

Liver, kidney, breast, endometrial, prostate, colon…Huge burden on healthcare cost:

25 % greater among subjects with a BMI 30 to 34.944 % greater among those with a BMI > 35

Treatment

TreatmentMedical treatment:

TreatmentMedical treatment:

Diet, exercise and life style modification.

TreatmentMedical treatment:

Diet, exercise and life style modification.Medications.

TreatmentMedical treatment:

Diet, exercise and life style modification.Medications.

Surgical treatment:

TreatmentMedical treatment:

Diet, exercise and life style modification.Medications.

Surgical treatment:Roux-en-Y Gastric By-pass.

TreatmentMedical treatment:

Diet, exercise and life style modification.Medications.

Surgical treatment:Roux-en-Y Gastric By-pass.Adjustable Gastric Banding.

TreatmentMedical treatment:

Diet, exercise and life style modification.Medications.

Surgical treatment:Roux-en-Y Gastric By-pass.Adjustable Gastric Banding.Diet, exercise and life style modification are part of surgical

treatment.

Dietary and Exercise recommendation after Gastric Bypass

Dietary and Exercise recommendation after Gastric BypassDiet:

1200-1400 Cal per day.60-80 g protein per day.4-5 small meals (especially breakfast).32 oz water per day.

Dietary and Exercise recommendation after Gastric BypassDiet:

1200-1400 Cal per day.60-80 g protein per day.4-5 small meals (especially breakfast).32 oz water per day.

Exercise:Walking 30 min/day, five to seven days per week.

Roux en Y Gastric By-pass

Adjustable Gastric band

Weight Loss after Gastric Bypass

Weight Loss after Gastric BypassHow do Age, Gender and BMI influence weight loss?

Weight Loss after Gastric BypassHow do Age, Gender and BMI influence weight loss?Recent work done by Dr Caruana:

Weight Loss after Gastric BypassHow do Age, Gender and BMI influence weight loss?Recent work done by Dr Caruana:

Weight Loss Curves.

Weight Loss after Gastric BypassHow do Age, Gender and BMI influence weight loss?Recent work done by Dr Caruana:

Weight Loss Curves.Effect of Age, Gender and BMI on weight loss.

959075

50

25 10 5

9590755025 10 5

Red Lines >41 yrBlack Lines <41 yr

Red Lines FemalesBlack Lines Males

9590755025 10 5

Red Lines BMI>55Black Lines BMI<55

9590755025 10 5

Sub-Optimal Weight Loss (SWL)

Sub-Optimal Weight Loss (SWL)SWL < 40% (to 50%) Excess Body Weight (EBW) lost.

Sub-Optimal Weight Loss (SWL)SWL < 40% (to 50%) Excess Body Weight (EBW) lost.EBW is actual weight minus Ideal Body Weight (IBW).

Sub-Optimal Weight Loss (SWL)SWL < 40% (to 50%) Excess Body Weight (EBW) lost.EBW is actual weight minus Ideal Body Weight (IBW).IBW from 1983 Metropolitan Height and Weight Tables.

Sub-Optimal Weight Loss (SWL)SWL < 40% (to 50%) Excess Body Weight (EBW) lost.EBW is actual weight minus Ideal Body Weight (IBW).IBW from 1983 Metropolitan Height and Weight Tables.Around 10% (to 20%) of Gastric Bypass patients have

SWL:

Sub-Optimal Weight Loss (SWL)SWL < 40% (to 50%) Excess Body Weight (EBW) lost.EBW is actual weight minus Ideal Body Weight (IBW).IBW from 1983 Metropolitan Height and Weight Tables.Around 10% (to 20%) of Gastric Bypass patients have

SWL:Most of the patients actually regain the weight.

Methods

MethodsMatched Case-Control Study.

MethodsMatched Case-Control Study.Controls matched to cases for Age, Gender & BMI.

MethodsMatched Case-Control Study.Controls matched to cases for Age, Gender & BMI. Four matched controls for every case.

Inclusion/Exclusion Criteria

Inclusion/Exclusion CriteriaGastric bypass between Jan ’00 and Dec ‘07.

Inclusion/Exclusion CriteriaGastric bypass between Jan ’00 and Dec ‘07. Followed up at 18 (±2) months after surgery.

Inclusion/Exclusion CriteriaGastric bypass between Jan ’00 and Dec ‘07. Followed up at 18 (±2) months after surgery. At 18 (± 2) months:

Inclusion/Exclusion CriteriaGastric bypass between Jan ’00 and Dec ‘07. Followed up at 18 (±2) months after surgery. At 18 (± 2) months:

If lost < 40% EBW—Case.

Inclusion/Exclusion CriteriaGastric bypass between Jan ’00 and Dec ‘07. Followed up at 18 (±2) months after surgery. At 18 (± 2) months:

If lost < 40% EBW—Case. If lost >40% EBW—Potential Control.

Cases Controls

Break Down of Cases & Controls

Cases Controls

Number 21 84

Break Down of Cases & Controls

Cases Controls

Number 21 84

Gender

FemalesMales

201

804

Break Down of Cases & Controls

Cases Controls

Number 21 84

Gender

FemalesMales

201

804

Age (Years) MeanRange

4535

4538

Break Down of Cases & Controls

Cases Controls

Number 21 84

Gender

FemalesMales

201

804

Age (Years) MeanRange

4535

4538

BMI MeanRange

5537

5540

Break Down of Cases & Controls

Cases Controls

Number 21 84

Gender

FemalesMales

201

804

Age (Years) MeanRange

4535

4538

BMI MeanRange

5537

5540

Working (%) YesNo

6040

6436

Break Down of Cases & Controls

Cases Controls

Number 21 84

Gender

FemalesMales

201

804

Age (Years) MeanRange

4535

4538

BMI MeanRange

5537

5540

Working (%) YesNo

6040

6436

Smoking (%) YesNo

1090

1783

Break Down of Cases & Controls

Cases Controls

Number 21 84

Gender

FemalesMales

201

804

Age (Years) MeanRange

4535

4538

BMI MeanRange

5537

5540

Working (%) YesNo

6040

6436

Smoking (%) YesNo

1090

1783

Race (%) WhiteBlack

9010

8317

Break Down of Cases & Controls

Data CollectionRetrospective Chart Review.

Data CollectionRetrospective Chart Review.Variables:

Data CollectionRetrospective Chart Review.Variables:

DemographicAnthropometricSocialComplianceDisease CharacteristicsCo-morbiditiesRelated DiseasesPeri-operative

Type of Variable

Variables

Demographic Race, (Age and Gender Matched)

Type of Variable

Variables

Demographic Race, (Age and Gender Matched)

Anthropometric (BMI Matched)

Type of Variable

Variables

Demographic Race, (Age and Gender Matched)

Anthropometric (BMI Matched)

Social Work StatusSmoking Status

Type of Variable

Variables

Demographic Race, (Age and Gender Matched)

Anthropometric (BMI Matched)

Social Work StatusSmoking Status

Compliance Total Number of Follow-up VisitsDietary Compliance at Follow-upExercise Compliance at Follow-up

Type of Variable

Variables

Demographic Race, (Age and Gender Matched)

Anthropometric (BMI Matched)

Social Work StatusSmoking Status

Compliance Total Number of Follow-up VisitsDietary Compliance at Follow-upExercise Compliance at Follow-up

Disease Characteristics

Duration of ObesityFamily H/O Obesity

Type of Variable

Variables

Demographic Race, (Age and Gender Matched)

Anthropometric (BMI Matched)

Social Work StatusSmoking Status

Compliance Total Number of Follow-up VisitsDietary Compliance at Follow-upExercise Compliance at Follow-up

Disease Characteristics

Duration of ObesityFamily H/O Obesity

Co-morbidities No. of Co-morbidities (DM, HTN, Dyslipidemia, OSA, Arthritis, and GERD)Hepatic SteatosisNo. of Prescription MedicationsSeverity of DM, HTN and Dyslipidemia

Type of Variable

Variables

Demographic Race, (Age and Gender Matched)

Anthropometric (BMI Matched)

Social Work StatusSmoking Status

Compliance Total Number of Follow-up VisitsDietary Compliance at Follow-upExercise Compliance at Follow-up

Disease Characteristics

Duration of ObesityFamily H/O Obesity

Co-morbidities No. of Co-morbidities (DM, HTN, Dyslipidemia, OSA, Arthritis, and GERD)Hepatic SteatosisNo. of Prescription MedicationsSeverity of DM, HTN and Dyslipidemia

Related Diseases DepressionThyroid DysfunctionH/O Major Surgeries

Type of Variable

Variables

Demographic Race, (Age and Gender Matched)

Anthropometric (BMI Matched)

Social Work StatusSmoking Status

Compliance Total Number of Follow-up VisitsDietary Compliance at Follow-upExercise Compliance at Follow-up

Disease Characteristics

Duration of ObesityFamily H/O Obesity

Co-morbidities No. of Co-morbidities (DM, HTN, Dyslipidemia, OSA, Arthritis, and GERD)Hepatic SteatosisNo. of Prescription MedicationsSeverity of DM, HTN and Dyslipidemia

Related Diseases DepressionThyroid DysfunctionH/O Major Surgeries

Peri-operative Cholecystectomy done at ORPost-op LeakPost-op PEReturn to OR in 30 days

Statistical Analysis

Statistical AnalysisBinary predictors between the case and control group—

the exact Cochran-Mantel-Haenszel test:

Statistical AnalysisBinary predictors between the case and control group—

the exact Cochran-Mantel-Haenszel test:Common odds ratio with a corresponding exact 95%

confidence interval was estimated.

Statistical AnalysisBinary predictors between the case and control group—

the exact Cochran-Mantel-Haenszel test:Common odds ratio with a corresponding exact 95%

confidence interval was estimated.Mixed linear—Between-group Mean Difference.

Statistical AnalysisBinary predictors between the case and control group—

the exact Cochran-Mantel-Haenszel test:Common odds ratio with a corresponding exact 95%

confidence interval was estimated.Mixed linear—Between-group Mean Difference. A nominal significance level of 0.05 was used.

Statistical AnalysisBinary predictors between the case and control group—

the exact Cochran-Mantel-Haenszel test:Common odds ratio with a corresponding exact 95%

confidence interval was estimated.Mixed linear—Between-group Mean Difference. A nominal significance level of 0.05 was used.A multivariate model was constructed using a stepwise

conditional logistic regression procedure.

Statistical AnalysisBinary predictors between the case and control group—

the exact Cochran-Mantel-Haenszel test:Common odds ratio with a corresponding exact 95%

confidence interval was estimated.Mixed linear—Between-group Mean Difference. A nominal significance level of 0.05 was used.A multivariate model was constructed using a stepwise

conditional logistic regression procedure.SAS version 9.1.3 statistical software (Cary, NC).

Variable OR 95% CI p- Value

Diabetes Y vs. N 0.6 (0.1931, 2.4302) 0.567

Binary Predictors—the exact Cochran-Mantel-Haenszel test

Variable OR 95% CI p- Value

Diabetes Y vs. N 0.6 (0.1931, 2.4302) 0.567

Binary Predictors—the exact Cochran-Mantel-Haenszel test

Binary Predictor—Yes or No

Variable OR 95% CI p- Value

Diabetes Y vs. N 0.6 (0.1931, 2.4302) 0.567

Binary Predictors—the exact Cochran-Mantel-Haenszel test

Binary Predictor—Yes or No

Odds of normal weight loss if DM =0.6Odds of normal weight loss if not DM

Variable OR 95% CI p- Value

Diabetes Y vs. N 0.6 (0.1931, 2.4302) 0.567

Binary Predictors—the exact Cochran-Mantel-Haenszel test

Binary Predictor—Yes or No

Odds of normal weight loss if DM =0.6Odds of normal weight loss if not DM

95% Confidence that OR lies between (0.1931, 2.4302)

Variable OR 95% CI p- Value

Diabetes Y vs. N 0.6 (0.1931, 2.4302) 0.567

Binary Predictors—the exact Cochran-Mantel-Haenszel test

Binary Predictor—Yes or No

Odds of normal weight loss if DM =0.6Odds of normal weight loss if not DM

95% Confidence that OR lies between (0.1931, 2.4302)

P-Value < 0.05 for a relationship to be statistically significant, otherwise could be just by chance

Variable Estimated Mean Difference(Control—Case)

95% CI p- Value

No. of Medications @ follow-up -1.4 (0.5079, 2.4206) 0.0031

Mixed Linear Models—Between-group mean difference

Variable Estimated Mean Difference(Control—Case)

95% CI p- Value

No. of Medications @ follow-up -1.4 (0.5079, 2.4206) 0.0031

Mixed Linear Models—Between-group mean difference

Linear Variable—Number

Variable Estimated Mean Difference(Control—Case)

95% CI p- Value

No. of Medications @ follow-up -1.4 (0.5079, 2.4206) 0.0031

Mixed Linear Models—Between-group mean difference

Linear Variable—Number

Average number of extra medications taken by Controls

Results—UnivariateVariable Comment

Results—UnivariateVariable Comment

Demographic RaceAgeGender

InsignificantMatchedMatched

Results—UnivariateVariable Comment

Demographic RaceAgeGender

InsignificantMatchedMatched

Anthropometric BMI Matched

Results—UnivariateVariable Comment

Demographic RaceAgeGender

InsignificantMatchedMatched

Anthropometric BMI Matched

Social Work StatusSmoking Status

InsignificantInsignificant

Results—UnivariateVariable Comment

Demographic RaceAgeGender

InsignificantMatchedMatched

Anthropometric BMI Matched

Social Work StatusSmoking Status

InsignificantInsignificant

Compliance Total Number of Follow-up VisitsDietary Compliance at Follow-upExercise Compliance at Follow-up

InsignificantSignificantInsignificant

Results—UnivariateVariable Comment

Demographic RaceAgeGender

InsignificantMatchedMatched

Anthropometric BMI Matched

Social Work StatusSmoking Status

InsignificantInsignificant

Compliance Total Number of Follow-up VisitsDietary Compliance at Follow-upExercise Compliance at Follow-up

InsignificantSignificantInsignificant

Disease Characteristics

Duration of ObesityFamily H/O Obesity

InsignificantInsignificant

Results—UnivariateVariables Comment

Results—UnivariateVariables Comment

Co-morbidities No. of Co-morbiditiesHepatic SteatosisDM

InsignificantInsignificantInsignificant

Results—UnivariateVariables Comment

Co-morbidities No. of Co-morbiditiesHepatic SteatosisDM

InsignificantInsignificantInsignificant

DyslipidemiaOn Anti-dyslipidemic Medications @ Baseline @Follow-up

Insignificant

InsignificantInsignificant

Results—UnivariateVariables Comment

Co-morbidities No. of Co-morbiditiesHepatic SteatosisDM

InsignificantInsignificantInsignificant

DyslipidemiaOn Anti-dyslipidemic Medications @ Baseline @Follow-up

Insignificant

InsignificantInsignificant

HTN On Anti-HTN Medications @ Baseline @Follow-up

Insignificant

SignificantInsignificant

Results—UnivariateVariables Comment

Co-morbidities No. of Co-morbiditiesHepatic SteatosisDM

InsignificantInsignificantInsignificant

DyslipidemiaOn Anti-dyslipidemic Medications @ Baseline @Follow-up

Insignificant

InsignificantInsignificant

HTN On Anti-HTN Medications @ Baseline @Follow-up

Insignificant

SignificantInsignificant

Prescription Medications @ Baseline @Follow-up

InsignificantSignificant

Results—UnivariateVariable Comment

Results—UnivariateVariable Comment

Related Diseases H/O DepressionH/O Thyroid dysfunctionH/O Major Surgeries

InsignificantInsignificantInsignificant

Results—UnivariateVariable Comment

Related Diseases H/O DepressionH/O Thyroid dysfunctionH/O Major Surgeries

InsignificantInsignificantInsignificant

Peri-operative Cholecystectomy done at ORPost-op LeakPost-op PEReturn to OR in 30 days

InsignificantInsignificantInsignificantInsignificant

Variable

Compliance Dietary Compliance at Follow-up Significant

Co-morbidities Prescriptions Medications at Follow-up Significant

Results—Multivariate

ConclusionAfter negating effects of Age, Gender and BMI:

Dietary non-compliance (reported by patients) predisposes to SWL.

ConclusionAfter negating effects of Age, Gender and BMI:

Dietary non-compliance (reported by patients) predisposes to SWL.

This should be stressed to patients before and after gastric bypass surgery.

ConclusionAfter negating effects of Age, Gender and BMI:

Dietary non-compliance (reported by patients) predisposes to SWL.

This should be stressed to patients before and after gastric bypass surgery.

“Self-reported loss of control over eating was related to weight regain after Gastric Bypass surgery and may be an important target for clinical intervention” (Kalarchian, Obes Surg 2002 Apr;12(2):270-5).

ConclusionAfter negating effects of Age, Gender and BMI:

Dietary non-compliance (reported by patients) predisposes to SWL.

This should be stressed to patients before and after gastric bypass surgery.

“Self-reported loss of control over eating was related to weight regain after Gastric Bypass surgery and may be an important target for clinical intervention” (Kalarchian, Obes Surg 2002 Apr;12(2):270-5).

Gradual enlargement of the gastric pouch.

Dietary and Exercise recommendation after Gastric BypassDiet:

1200-1400 Cal per day.60-80 g protein per day.4-5 small meals (especially breakfast).32 oz water per day.

Exercise:Walking 30 min/day, five to seven days per week.

Roux en Y Gastric By-pass

ConclusionAnti-HTN at baseline:

Probably a direct effect of a more serious disease and hence more SWL.

ConclusionAnti-HTN at baseline:

Probably a direct effect of a more serious disease and hence more SWL.

Prescription medications at follow-up:An indirect clue that patients who (were non-compliant and)

did not loose enough weight continued to need more medications.

Bigger and more powerful studies could potentially show other significant associations.

Conclusion

Bigger and more powerful studies could potentially show other significant associations.

Being a retrospective study, cause-effect relationship cannot be established—results show only associations.

Conclusion

Bigger and more powerful studies could potentially show other significant associations.

Being a retrospective study, cause-effect relationship cannot be established—results show only associations.

Data was partly patient reported/subjective- potential recall bias.

Conclusion

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