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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00998374
Enrollment
62
Registered
2009-10-20
Start date
2009-09-30
Completion date
2013-04-30
Last updated
2014-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoglycemia, Obesity

Brief summary

This study will compare glucose and simple carbohydrate sensitivity. The hypothesis is that rapid emptying of high-glycemic index foods after Roux-En-Y gastric bypass (RYGB) causes reactive hypoglycemia. It is believed that the controlled release offered by an intact pylorus will be advantageous for long term results in bariatric surgery. This study can provide a scientific rationale, in a short duration of time, for why pylorus sparing surgery, such as the sleeve gastrectomy or duodenal switch, may offer therapeutic advantages, as compared to non-pyloric sparing surgery, namely the gastric bypass.

Detailed description

Clinical Trial Objective: The objective of this clinical trial is to determine whether an intact pylorus prevents reactive hypoglycemia following challenge with liquid glucose preparation and/or solid load made of refined flour product that is a simple carbohydrate. Clinical Trial Design: This is a prospective, non-randomized, clinical trial.

Interventions

None listed

Sponsors

Medtronic - MITG
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* The patient is greater than 18 years old; * The patient has a BMI \> 35; * Patient meets standards for bariatric surgery;

Exclusion criteria

* The patient has an incurable malignant or debilitating disease; * The patient has been diagnosed with a severe eating disorder; * The patient is currently pregnant (pregnancy test required for confirmation for those of child bearing years); * The patient is unable to comply with the study requirements, follow-up schedule, or to give valid informed consent

Design outcomes

Primary

MeasureTime frameDescription
Mean Serum Glucose Levels30, 60, and 120 minutes at 6, 9, and 12 months post-operativelySerum glucose levels measured to assess reactive hypoglycemia status
Reactive Hypoglycemia Status6 months, 9 months, 12 months post-opPostoperative 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

Secondary

MeasureTime frameDescription
Insulin Resistance6, 9, and 12 months post-operativelyMeasured by levels of post prandial insulin
Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing6, 9, and 12 months post-opSubjective 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

Countries

United States

Participant flow

Participants by arm

ArmCount
Pyloric-sparing
Pyloric sparing: Sleeve Gastrectomy and Duodenal Switch
39
Non-pyloric Sparing
Non-pyloric sparing: Roux-en-Y Gastric Bypass
23
Total62

Baseline characteristics

CharacteristicPyloric-sparingNon-pyloric SparingTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
39 Participants23 Participants62 Participants
Region of Enrollment
United States
39 participants23 participants62 participants
Sex: Female, Male
Female
24 Participants20 Participants44 Participants
Sex: Female, Male
Male
15 Participants3 Participants18 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
8 / 392 / 23
serious
Total, serious adverse events
5 / 393 / 23

Outcome results

Primary

Mean Serum Glucose Levels

Serum glucose levels measured to assess reactive hypoglycemia status

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

ArmMeasureGroupValue (MEAN)Dispersion
Pyloric-sparingMean Serum Glucose Levels6 months - 60 minutes121.8 mg/dlStandard Deviation 65.6
Pyloric-sparingMean Serum Glucose Levels12 months - 60 minutes121.1 mg/dlStandard Deviation 52.3
Pyloric-sparingMean Serum Glucose Levels9 months - 30 minutes103.2 mg/dlStandard Deviation 30.2
Pyloric-sparingMean Serum Glucose Levels6 months - 120 minutes83.4 mg/dlStandard Deviation 48.4
Pyloric-sparingMean Serum Glucose Levels6 months - 30 minutes123.1 mg/dlStandard Deviation 48.8
Pyloric-sparingMean Serum Glucose Levels9 months - 120 minutes88.3 mg/dlStandard Deviation 33.1
Pyloric-sparingMean Serum Glucose Levels12 months - 30 minutes130.3 mg/dlStandard Deviation 49.6
Pyloric-sparingMean Serum Glucose Levels12 months - 120 minutes84.5 mg/dlStandard Deviation 52.1
Pyloric-sparingMean Serum Glucose Levels9 months - 60 minutes98.8 mg/dlStandard Deviation 34.9
Non-pyloric SparingMean Serum Glucose Levels12 months - 120 minutes79.5 mg/dlStandard Deviation 58.6
Non-pyloric SparingMean Serum Glucose Levels9 months - 60 minutes132.6 mg/dlStandard Deviation 65.2
Non-pyloric SparingMean Serum Glucose Levels6 months - 30 minutes157.5 mg/dlStandard Deviation 56.2
Non-pyloric SparingMean Serum Glucose Levels9 months - 30 minutes138 mg/dlStandard Deviation 50.1
Non-pyloric SparingMean Serum Glucose Levels12 months - 30 minutes173.4 mg/dlStandard Deviation 78.3
Non-pyloric SparingMean Serum Glucose Levels12 months - 60 minutes141.8 mg/dlStandard Deviation 90.7
Non-pyloric SparingMean Serum Glucose Levels6 months - 120 minutes83.4 mg/dlStandard Deviation 45.9
Non-pyloric SparingMean Serum Glucose Levels9 months - 120 minutes85.3 mg/dlStandard Deviation 41.3
Non-pyloric SparingMean Serum Glucose Levels6 months - 60 minutes152.6 mg/dlStandard Deviation 79.6
Primary

Reactive Hypoglycemia Status

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

Time frame: 6 months, 9 months, 12 months post-op

ArmMeasureGroupValue (NUMBER)
Pyloric-sparingReactive Hypoglycemia Status6 Month11 participants
Pyloric-sparingReactive Hypoglycemia Status9 Month4 participants
Pyloric-sparingReactive Hypoglycemia Status12 Month7 participants
Non-pyloric SparingReactive Hypoglycemia Status6 Month6 participants
Non-pyloric SparingReactive Hypoglycemia Status9 Month3 participants
Non-pyloric SparingReactive Hypoglycemia Status12 Month7 participants
Secondary

Insulin Resistance

Measured by levels of post prandial insulin

Time frame: 6, 9, and 12 months post-operatively

ArmMeasureGroupValue (MEAN)Dispersion
Pyloric-sparingInsulin Resistance1 hour pp - 6 month13.7 pmol/LStandard Deviation 11.7
Pyloric-sparingInsulin Resistance1 hour pp - 9 month6.4 pmol/LStandard Deviation 3.2
Pyloric-sparingInsulin Resistance1 hour pp - 12 month10.9 pmol/LStandard Deviation 9.3
Pyloric-sparingInsulin Resistance2 hours pp - 6 month3.8 pmol/LStandard Deviation 2.5
Pyloric-sparingInsulin Resistance2 hours pp - 9 month2.6 pmol/LStandard Deviation 2.3
Pyloric-sparingInsulin Resistance2 hours pp - 12 month4.8 pmol/LStandard Deviation 12.4
Non-pyloric SparingInsulin Resistance2 hours pp - 9 month4.2 pmol/LStandard Deviation 4.9
Non-pyloric SparingInsulin Resistance1 hour pp - 6 month21.2 pmol/LStandard Deviation 16.4
Non-pyloric SparingInsulin Resistance2 hours pp - 6 month3.9 pmol/LStandard Deviation 6.7
Non-pyloric SparingInsulin Resistance1 hour pp - 9 month20.9 pmol/LStandard Deviation 25.1
Non-pyloric SparingInsulin Resistance2 hours pp - 12 month6.6 pmol/LStandard Deviation 12.3
Non-pyloric SparingInsulin Resistance1 hour pp - 12 month16.7 pmol/LStandard Deviation 14.6
Secondary

Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing

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

Time frame: 6, 9, and 12 months post-op

ArmMeasureGroupValue (NUMBER)
Pyloric-sparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing12 Month - Nausea5 participants
Pyloric-sparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing6 Month - Headache4 participants
Pyloric-sparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing6 Month - Hunger4 participants
Pyloric-sparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing9 Month - Hunger0 participants
Pyloric-sparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing12 Month - Hunger2 participants
Pyloric-sparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing9 Month - Headache3 participants
Pyloric-sparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing12 Month - Headache4 participants
Pyloric-sparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing6 Month - Dizziness10 participants
Pyloric-sparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing9 Month - Dizziness1 participants
Pyloric-sparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing12 Month - Dizziness0 participants
Pyloric-sparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing6 Month - Sweating4 participants
Pyloric-sparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing9 Month - Sweating0 participants
Pyloric-sparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing12 Month - Sweating0 participants
Pyloric-sparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing6 Month - Weakness6 participants
Pyloric-sparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing9 Month - Weakness1 participants
Pyloric-sparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing12 Month - Weakness2 participants
Pyloric-sparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing6 Month - Nausea12 participants
Pyloric-sparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing9 Month - Nausea2 participants
Non-pyloric SparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing6 Month - Weakness8 participants
Non-pyloric SparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing12 Month - Dizziness3 participants
Non-pyloric SparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing6 Month - Headache3 participants
Non-pyloric SparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing12 Month - Nausea6 participants
Non-pyloric SparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing9 Month - Nausea6 participants
Non-pyloric SparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing6 Month - Hunger3 participants
Non-pyloric SparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing6 Month - Sweating2 participants
Non-pyloric SparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing9 Month - Hunger2 participants
Non-pyloric SparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing9 Month - Weakness3 participants
Non-pyloric SparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing12 Month - Hunger1 participants
Non-pyloric SparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing9 Month - Sweating2 participants
Non-pyloric SparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing9 Month - Headache3 participants
Non-pyloric SparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing6 Month - Nausea8 participants
Non-pyloric SparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing12 Month - Headache3 participants
Non-pyloric SparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing12 Month - Sweating2 participants
Non-pyloric SparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing6 Month - Dizziness7 participants
Non-pyloric SparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing12 Month - Weakness6 participants
Non-pyloric SparingSubjective Symptoms of Hypoglycemia During Glucose Tolerance Testing9 Month - Dizziness4 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026