Diabetes, Obesity
Conditions
Brief summary
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).
Detailed description
Same as brief summary
Interventions
None listed
Sponsors
University of South Alabama
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age \> 19 years of age and \<70 years of age * HGA1c\<6.0% * fasting blood sugar less than 100mg/dL
Exclusion criteria
* Taking antidiabetic medications for other indications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure Erythrocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure Adipocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | 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. | 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. |
| 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 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Type 2 Diabetic morbidly obese type 2 diabetic patients | 16 |
| Nondiabetic morbidly obese nondiabetic patients | 11 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 3 |
Baseline characteristics
| Characteristic | Type 2 Diabetic | Nondiabetic | Total |
|---|---|---|---|
| Age, Continuous | 47.20 years STANDARD_DEVIATION 2.52 | 44 years STANDARD_DEVIATION 3.4 | 45.6 years STANDARD_DEVIATION 2.96 |
| body mass index | 45.61 kilograms per meter squared STANDARD_DEVIATION 2.61 | 47.72 kilograms per meter squared STANDARD_DEVIATION 2.92 | 46.67 kilograms per meter squared STANDARD_DEVIATION 2.77 |
| cholesterol | 199.10 mg/dL STANDARD_DEVIATION 12.23 | 208.70 mg/dL STANDARD_DEVIATION 11.9 | 203.9 mg/dL STANDARD_DEVIATION 12.07 |
| fasting glucose | 207 mg/dL STANDARD_DEVIATION 17.69 | 93.08 mg/dL STANDARD_DEVIATION 2.5 | 150.04 mg/dL STANDARD_DEVIATION 10.1 |
| fasting insulin | 54.89 mIU/L STANDARD_DEVIATION 19.55 | 36.49 mIU/L STANDARD_DEVIATION 12.75 | 45.69 mIU/L STANDARD_DEVIATION 16.15 |
| hemoglobin A 1 c | 9.38 percent of HbA1c STANDARD_DEVIATION 0.62 | 5.52 percent of HbA1c STANDARD_DEVIATION 0.06 | 7.45 percent of HbA1c STANDARD_DEVIATION 0.34 |
| homeostatic model assessment insulin resistent | 30.51 HOMA-IR score STANDARD_DEVIATION 11.98 | 8.50 HOMA-IR score STANDARD_DEVIATION 3.1 | 19.51 HOMA-IR score STANDARD_DEVIATION 7.54 |
| Sex: Female, Male Female | 9 Participants | 6 Participants | 15 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 12 Participants |
| triglycerides | 283.1 mg/dL STANDARD_DEVIATION 56.25 | 202.40 mg/dL STANDARD_DEVIATION 43.61 | 242.75 mg/dL STANDARD_DEVIATION 49.93 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 11 |
| serious Total, serious adverse events | 0 / 16 | 0 / 11 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diabetic | Measure Erythrocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | Baseline | 3.12 nM/min/mg | Standard Deviation 5.22 |
| Diabetic | Measure Erythrocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | 1 week post surgery | 22 nM/min/mg | Standard Deviation 1.39 |
| Diabetic | Measure Erythrocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | 6 week post surgery | 20 nM/min/mg | Standard Deviation 1.39 |
| Diabetic | Measure Erythrocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | 12 week post surgery | 7.58 nM/min/mg | Standard Deviation 9.81 |
| Nondiabetic | Measure Erythrocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | 12 week post surgery | 11.72 nM/min/mg | Standard Deviation 14.38 |
| Nondiabetic | Measure Erythrocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | Baseline | 0.67 nM/min/mg | Standard Deviation 0.46 |
| Nondiabetic | Measure Erythrocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | 6 week post surgery | 12 nM/min/mg | Standard Deviation 0.14 |
| Nondiabetic | Measure Erythrocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | 1 week post surgery | 13 nM/min/mg | Standard Deviation 0.14 |
p-value: <0.05Wilcoxon (Mann-Whitney)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diabetic | Measure Adipocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | Baseline | 3.12 nM/min/mg | Standard Error 1.39 |
| Diabetic | Measure Adipocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | 1 week postop | 22.1 nM/min/mg | Standard Error 3.5 |
| Diabetic | Measure Adipocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | 6 weeks | 21.9 nM/min/mg | Standard Error 3.2 |
| Diabetic | Measure Adipocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | 12 weeks post surgery | 8 nM/min/mg | Standard Error 2 |
| Nondiabetic | Measure Adipocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | 12 weeks post surgery | 4.9 nM/min/mg | Standard Error 1.5 |
| Nondiabetic | Measure Adipocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | Baseline | 0.67 nM/min/mg | Standard Error 0.14 |
| Nondiabetic | Measure Adipocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | 6 weeks | 12.5 nM/min/mg | Standard Error 2.7 |
| Nondiabetic | Measure Adipocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | 1 week postop | 13 nM/min/mg | Standard Error 2.8 |
Secondary
Measure Hepatocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass.
Time frame: time of gastric bypass
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetic | Measure Hepatocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | 17 nM/min/mg | Standard Error 2 |
| Nondiabetic | Measure Hepatocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | 11.9 nM/min/mg | Standard Error 2.1 |
Secondary
Measure Omentum G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass.
Time frame: time of gastric bypass
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetic | Measure Omentum G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | 13 nM/min/mg | Standard Error 3 |
| Nondiabetic | Measure Omentum G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. | 12 nM/min/mg | Standard Error 2 |