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This study compares the improvement of weight, fasting lipid profile (triglycerides, cholesterol, HDL, and LDL) and diabetes after gastric bypass surgery with an improvement in levels of an enzyme called glucose-6-phosphate dehydrogenase (G6PD).
Same as brief summary
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| Measure | Description | Time Frame |
|---|---|---|
| Measure Erythrocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | G6PD levels will be measured various time intervals. G6PD is the rate limiting enzyme of the pentose phosphate pathway that provides NADPH required for lipid synthesis. G6PD overexpression is implicated in insulin resistance, hyperlipidemia and increases in oxidative stress. | G6PD levels will be measured at the following time intervals: Baseline(prior to gastric bypass surgery), 1 week, 6 weeks, and 12 weeks post surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Measure Adipocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | G6PD levels will be measured various time intervals. G6PD is the rate limiting enzyme of the pentose phosphate pathway that provides NADPH required for lipid synthesis. G6PD overexpression is implicated in insulin resistance, hyperlipidemia and increases in oxidative stress. |
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Inclusion Criteria:
Exclusion Criteria:
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All patients will be morbidly obese and undergo Roux-en-Y Gastric bypass surgery. Both Type 2 diabetic and non-diabetic patients will be accepted into the study.
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| Name | Affiliation | Role |
|---|---|---|
| William O Richards, MD | University of South Alabama, Department of Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile Infirmary Medical Center | Mobile | Alabama | 36607 | United States | ||
| University of South Alabama |
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| ID | Title | Description |
|---|---|---|
| FG000 | Type 2 Diabetic | morbidly obese type 2 diabetic patients |
| FG001 | Nondiabetic | morbidly obese nondiabetic patients |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Type 2 Diabetic | morbidly obese type 2 diabetic patients |
| BG001 | Nondiabetic | morbidly obese nondiabetic patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Measure Erythrocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | G6PD levels will be measured various time intervals. G6PD is the rate limiting enzyme of the pentose phosphate pathway that provides NADPH required for lipid synthesis. G6PD overexpression is implicated in insulin resistance, hyperlipidemia and increases in oxidative stress. | Posted | Mean | Standard Deviation | nM/min/mg | G6PD levels will be measured at the following time intervals: Baseline(prior to gastric bypass surgery), 1 week, 6 weeks, and 12 weeks post surgery. |
|
baseline to 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Type 2 Diabetic | no adverse events occurred |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. William O. Richards | University of South Alabama, Department of Surgery | 251-471-7993 | brichards@health.southalabama.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Blood and tissue samples(adipose, omentum and liver biopsies)
| G6PD levels will be measured at the following time intervals: Baseline(prior to gastric bypass surgery), 1 week, 6 weeks, and 12 weeks post surgery. |
| Measure Omentum G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | time of gastric bypass |
| Measure Hepatocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | time of gastric bypass |
| Mobile |
| Alabama |
| 36617 |
| United States |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| body mass index | Mean | Standard Deviation | kilograms per meter squared |
|
| cholesterol | Mean | Standard Deviation | mg/dL |
|
| triglycerides | Mean | Standard Deviation | mg/dL |
|
| fasting insulin | Mean | Standard Deviation | mIU/L |
|
| homeostatic model assessment insulin resistent | The HOMA(IR) is a highly specific tool in measuring insulin resistance in patients in both diagnosis of diabetes and its treatment. HOMA IR is calculated from blood fasting insulin concentration (μU/ml) × fasting glucose concentration (mmol/L)/22.5 and must be taken at the same point in time. Normal healthy subjects have a HOMA(IR) of 1 while subjects with type 2 diabetes have elevated levels of HOMA IR. Higher levels indicate more insulin resistance and therefore a worse outcome measure. | Mean | Standard Deviation | HOMA-IR score |
|
| hemoglobin A 1 c | Mean | Standard Deviation | percent of HbA1c |
|
| fasting glucose | Mean | Standard Deviation | mg/dL |
|
|
|
|
| Secondary | Measure Adipocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | G6PD levels will be measured various time intervals. G6PD is the rate limiting enzyme of the pentose phosphate pathway that provides NADPH required for lipid synthesis. G6PD overexpression is implicated in insulin resistance, hyperlipidemia and increases in oxidative stress. | Posted | Mean | Standard Error | nM/min/mg | G6PD levels will be measured at the following time intervals: Baseline(prior to gastric bypass surgery), 1 week, 6 weeks, and 12 weeks post surgery. |
|
|
|
| Secondary | Measure Omentum G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | Posted | Mean | Standard Error | nM/min/mg | time of gastric bypass |
|
|
|
| Secondary | Measure Hepatocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | Posted | Mean | Standard Error | nM/min/mg | time of gastric bypass |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Nondiabetic | no adverse events occurred | 0 | 11 | 0 | 11 |
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| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 6 weeks |
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| 12 weeks post surgery |
|