Trial Outcomes & Findings for Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge (NCT NCT00998374)

NCT ID: NCT00998374

Last Updated: 2014-04-21

Results Overview

Serum glucose levels measured to assess reactive hypoglycemia status

• Recruitment status: COMPLETED
• Target enrollment: 62 participants
• Primary outcome timeframe: 30, 60, and 120 minutes at 6, 9, and 12 months post-operatively
• Results posted on: 2014-04-21

Participant Flow

Participant milestones

Measure	Pyloric-sparing Pyloric: Sleeve Gastrectomy (SG) \& Duodenal Switch (DS)	Non-pyloric Sparing Non-pyloric sparing: Roux-en-Y Gastric Bypass (RYGB)
Overall Study STARTED	39	23
Overall Study COMPLETED	27	12
Overall Study NOT COMPLETED	12	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge

Baseline characteristics by cohort

Measure	Pyloric-sparing n=39 Participants Pyloric sparing: Sleeve Gastrectomy and Duodenal Switch	Non-pyloric Sparing n=23 Participants Non-pyloric sparing: Roux-en-Y Gastric Bypass	Total n=62 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants	23 Participants n=7 Participants	62 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	20 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	3 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants	23 participants n=7 Participants	62 participants n=5 Participants

PRIMARY outcome

Timeframe: 30, 60, and 120 minutes at 6, 9, and 12 months post-operatively

Serum glucose levels measured to assess reactive hypoglycemia status

Outcome measures

Measure	Pyloric-sparing n=39 Participants Pyloric: SG \& DS	Non-pyloric Sparing n=23 Participants Non-pyloric sparing: RYGB
Mean Serum Glucose Levels 6 months - 30 minutes	123.1 mg/dl Standard Deviation 48.8	157.5 mg/dl Standard Deviation 56.2
Mean Serum Glucose Levels 9 months - 30 minutes	103.2 mg/dl Standard Deviation 30.2	138 mg/dl Standard Deviation 50.1
Mean Serum Glucose Levels 12 months - 30 minutes	130.3 mg/dl Standard Deviation 49.6	173.4 mg/dl Standard Deviation 78.3
Mean Serum Glucose Levels 6 months - 60 minutes	121.8 mg/dl Standard Deviation 65.6	152.6 mg/dl Standard Deviation 79.6
Mean Serum Glucose Levels 9 months - 60 minutes	98.8 mg/dl Standard Deviation 34.9	132.6 mg/dl Standard Deviation 65.2
Mean Serum Glucose Levels 12 months - 60 minutes	121.1 mg/dl Standard Deviation 52.3	141.8 mg/dl Standard Deviation 90.7
Mean Serum Glucose Levels 6 months - 120 minutes	83.4 mg/dl Standard Deviation 48.4	83.4 mg/dl Standard Deviation 45.9
Mean Serum Glucose Levels 9 months - 120 minutes	88.3 mg/dl Standard Deviation 33.1	85.3 mg/dl Standard Deviation 41.3
Mean Serum Glucose Levels 12 months - 120 minutes	84.5 mg/dl Standard Deviation 52.1	79.5 mg/dl Standard Deviation 58.6

PRIMARY outcome

Timeframe: 6 months, 9 months, 12 months post-op

Postoperative reactive hypoglycemia was defined as either

• serum glucose <60 mg/dL at least 1 hour after initiation of glucose tolerance testing
• serum glucose decrease ≥100 mg/dL within 1 hour after initiation of glucose tolerance testing

Outcome measures

Measure	Pyloric-sparing n=39 Participants Pyloric: SG \& DS	Non-pyloric Sparing n=23 Participants Non-pyloric sparing: RYGB
Reactive Hypoglycemia Status 12 Month	7 participants	7 participants
Reactive Hypoglycemia Status 6 Month	11 participants	6 participants
Reactive Hypoglycemia Status 9 Month	4 participants	3 participants

SECONDARY outcome

Timeframe: 6, 9, and 12 months post-operatively

Measured by levels of post prandial insulin

Outcome measures

Measure	Pyloric-sparing n=39 Participants Pyloric: SG \& DS	Non-pyloric Sparing n=23 Participants Non-pyloric sparing: RYGB
Insulin Resistance 1 hour pp - 6 month	13.7 pmol/L Standard Deviation 11.7	21.2 pmol/L Standard Deviation 16.4
Insulin Resistance 1 hour pp - 9 month	6.4 pmol/L Standard Deviation 3.2	20.9 pmol/L Standard Deviation 25.1
Insulin Resistance 1 hour pp - 12 month	10.9 pmol/L Standard Deviation 9.3	16.7 pmol/L Standard Deviation 14.6
Insulin Resistance 2 hours pp - 6 month	3.8 pmol/L Standard Deviation 2.5	3.9 pmol/L Standard Deviation 6.7
Insulin Resistance 2 hours pp - 9 month	2.6 pmol/L Standard Deviation 2.3	4.2 pmol/L Standard Deviation 4.9
Insulin Resistance 2 hours pp - 12 month	4.8 pmol/L Standard Deviation 12.4	6.6 pmol/L Standard Deviation 12.3

SECONDARY outcome

Timeframe: 6, 9, and 12 months post-op

Subjective symptoms of hypoglycemia during glucose tolerance testing measured by patients' responses to a questionnaire about symptoms of Weakness, Nausea, Hunger, Headache, Dizziness, Diaphoresis graded on a yes/no response

Outcome measures

Measure	Pyloric-sparing n=39 Participants Pyloric: SG \& DS	Non-pyloric Sparing n=23 Participants Non-pyloric sparing: RYGB
Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing 6 Month - Weakness	6 participants	8 participants
Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing 9 Month - Weakness	1 participants	3 participants
Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing 12 Month - Weakness	2 participants	6 participants
Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing 6 Month - Nausea	12 participants	8 participants
Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing 9 Month - Nausea	2 participants	6 participants
Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing 12 Month - Nausea	5 participants	6 participants
Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing 6 Month - Hunger	4 participants	3 participants
Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing 9 Month - Hunger	0 participants	2 participants
Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing 12 Month - Hunger	2 participants	1 participants
Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing 6 Month - Headache	4 participants	3 participants
Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing 9 Month - Headache	3 participants	3 participants
Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing 12 Month - Headache	4 participants	3 participants
Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing 6 Month - Dizziness	10 participants	7 participants
Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing 9 Month - Dizziness	1 participants	4 participants
Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing 12 Month - Dizziness	0 participants	3 participants
Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing 6 Month - Sweating	4 participants	2 participants
Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing 9 Month - Sweating	0 participants	2 participants
Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing 12 Month - Sweating	0 participants	2 participants

Adverse Events

Pyloric-sparing

Serious events: 5 serious events

Other events: 8 other events

Deaths: 0 deaths

Non-pyloric Sparing

Serious events: 3 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pyloric-sparing n=39 participants at risk Pyloric: SG \& DS	Non-pyloric Sparing n=23 participants at risk Non-pyloric: RYGB
Gastrointestinal disorders Colitis	2.6% 1/39 • Number of events 1 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.	0.00% 0/23 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.
Surgical and medical procedures Anastamotic Leak	2.6% 1/39 • Number of events 1 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.	0.00% 0/23 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.
Vascular disorders DVT/PE	2.6% 1/39 • Number of events 1 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.	0.00% 0/23 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.
General disorders Lower Left Quadrant (LLQ) pain	2.6% 1/39 • Number of events 1 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.	0.00% 0/23 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.
Vascular disorders Portal and superior mesenteric venous thrombosis	2.6% 1/39 • Number of events 1 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.	0.00% 0/23 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.
General disorders Epigastric hernia	2.6% 1/39 • Number of events 1 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.	0.00% 0/23 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.
Blood and lymphatic system disorders Hypoalbuminemia	2.6% 1/39 • Number of events 1 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.	0.00% 0/23 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/39 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.	4.3% 1/23 • Number of events 1 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.
Infections and infestations Wound infection	0.00% 0/39 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.	4.3% 1/23 • Number of events 1 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.
Surgical and medical procedures Bleeding	0.00% 0/39 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.	4.3% 1/23 • Number of events 1 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.
Gastrointestinal disorders Enterocutaneous fistula	0.00% 0/39 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.	4.3% 1/23 • Number of events 1 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.

Other adverse events

Measure	Pyloric-sparing n=39 participants at risk Pyloric: SG \& DS	Non-pyloric Sparing n=23 participants at risk Non-pyloric: RYGB
Psychiatric disorders Anxiety	2.6% 1/39 • Number of events 1 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.	0.00% 0/23 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.
General disorders Fever	2.6% 1/39 • Number of events 1 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.	0.00% 0/23 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.
General disorders Hypovolemia	2.6% 1/39 • Number of events 1 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.	0.00% 0/23 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.
General disorders Hypoxic	5.1% 2/39 • Number of events 2 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.	0.00% 0/23 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.
General disorders Fatigue	2.6% 1/39 • Number of events 1 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.	0.00% 0/23 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.
General disorders Left Kidney Stone (left flank pain)	2.6% 1/39 • Number of events 1 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.	0.00% 0/23 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.
General disorders more than expected post-op pain	2.6% 1/39 • Number of events 1 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.	0.00% 0/23 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.
General disorders Nocturnal desaturation	2.6% 1/39 • Number of events 1 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.	0.00% 0/23 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.
Cardiac disorders Sinus tachycardia	2.6% 1/39 • Number of events 1 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.	0.00% 0/23 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.
Cardiac disorders SVT	2.6% 1/39 • Number of events 1 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.	0.00% 0/23 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.
Surgical and medical procedures Anastomotic stricture	2.6% 1/39 • Number of events 1 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.	0.00% 0/23 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.
Gastrointestinal disorders GERD	2.6% 1/39 • Number of events 1 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.	0.00% 0/23 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.
General disorders Mild tingling of the legs	2.6% 1/39 • Number of events 1 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.	0.00% 0/23 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.
Surgical and medical procedures Incomplete staple line	0.00% 0/39 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.	4.3% 1/23 • Number of events 1 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.
General disorders Severe vomiting	0.00% 0/39 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.	4.3% 1/23 • Number of events 1 • Day 0, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, 12 months During each visit study subjects were asked whether an adverse event had occurred, and their 'yes'/'no'responses were recorded on the corresponding visit CRFs.

Additional Information

Dr. Mitchell Roslin

Lenox Hill Hospital

Phone: 212-434-3285

Email: MRoslin@NSHS.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place