Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pyloric-sparing vs. non-pyloric sparing | Pyloric: SG & DS Non-pyloric: RYGB |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Mean Serum Glucose Levels | Serum glucose levels measured to assess reactive hypoglycemia status | 30, 60, and 120 minutes at 6, 9, and 12 months post-operatively |
| Reactive Hypoglycemia Status | Postoperative reactive hypoglycemia was defined as either
| 6 months, 9 months, 12 months post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Resistance | Measured by levels of post prandial insulin | 6, 9, and 12 months post-operatively |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients >18 years of age BMI greater than or equal to 35
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mitchell Roslin, MD | Lenox Hill Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lenox Hill Hospital 186 E76th Street, 1st Floor | New York | New York | 10021 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pyloric-sparing | Pyloric: Sleeve Gastrectomy (SG) & Duodenal Switch (DS) |
| FG001 | Non-pyloric Sparing | Non-pyloric sparing: Roux-en-Y Gastric Bypass (RYGB) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pyloric-sparing | Pyloric sparing: Sleeve Gastrectomy and Duodenal Switch |
| BG001 | Non-pyloric Sparing | Non-pyloric sparing: Roux-en-Y Gastric Bypass |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Serum Glucose Levels | Serum glucose levels measured to assess reactive hypoglycemia status | Posted | Mean | Standard Deviation | mg/dl | 30, 60, and 120 minutes at 6, 9, and 12 months post-operatively |
|
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pyloric-sparing | Pyloric: SG & DS |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mitchell Roslin | Lenox Hill Hospital | 212-434-3285 | MRoslin@NSHS.edu |
Not provided
| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
Not provided
Not provided
Not provided
Not provided
Not provided
| 6, 9, and 12 months post-op |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Insulin Resistance | Measured by levels of post prandial insulin | Posted | Mean | Standard Deviation | pmol/L | 6, 9, and 12 months post-operatively |
|
|
|
| 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 | Posted | Number | participants | 6, 9, and 12 months post-op |
|
|
|
| Primary | Reactive Hypoglycemia Status | Postoperative reactive hypoglycemia was defined as either
| Posted | Number | participants | 6 months, 9 months, 12 months post-op |
|
|
|
| 5 |
| 39 |
| 8 |
| 39 |
| EG001 | Non-pyloric Sparing | Non-pyloric: RYGB | 3 | 23 | 2 | 23 |
| Anastamotic Leak | Surgical and medical procedures | Systematic Assessment |
|
| DVT/PE | Vascular disorders | Systematic Assessment |
|
| Lower Left Quadrant (LLQ) pain | General disorders | Systematic Assessment |
|
| Portal and superior mesenteric venous thrombosis | Vascular disorders | Systematic Assessment |
|
| Epigastric hernia | General disorders | Systematic Assessment |
|
| Hypoalbuminemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Wound infection | Infections and infestations | Systematic Assessment |
|
| Bleeding | Surgical and medical procedures | Systematic Assessment |
|
| Enterocutaneous fistula | Gastrointestinal disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Hypovolemia | General disorders | Systematic Assessment |
|
| Hypoxic | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Left Kidney Stone (left flank pain) | General disorders | Systematic Assessment |
|
| more than expected post-op pain | General disorders | Systematic Assessment |
|
| Nocturnal desaturation | General disorders | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
|
| SVT | Cardiac disorders | Systematic Assessment |
|
| Anastomotic stricture | Surgical and medical procedures | Systematic Assessment |
|
| GERD | Gastrointestinal disorders | Systematic Assessment |
|
| Mild tingling of the legs | General disorders | Systematic Assessment |
|
| Incomplete staple line | Surgical and medical procedures | Systematic Assessment |
|
| Severe vomiting | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 1 hour pp - 12 month |
|
| 2 hours pp - 6 month |
|
| 2 hours pp - 9 month |
|
| 2 hours pp - 12 month |
|
| 12 Month - Weakness |
|
| 6 Month - Nausea |
|
| 9 Month - Nausea |
|
| 12 Month - Nausea |
|
| 6 Month - Hunger |
|
| 9 Month - Hunger |
|
| 12 Month - Hunger |
|
| 6 Month - Headache |
|
| 9 Month - Headache |
|
| 12 Month - Headache |
|
| 6 Month - Dizziness |
|
| 9 Month - Dizziness |
|
| 12 Month - Dizziness |
|
| 6 Month - Sweating |
|
| 9 Month - Sweating |
|
| 12 Month - Sweating |
|
| 12 Month |
|