Trial Outcomes & Findings for Erythrocyte and Adipocyte G6PD Activity Levels in Obesity (NCT NCT01322035)
NCT ID: NCT01322035
Last Updated: 2024-05-16
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
27 participants
Primary outcome timeframe
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.
Results posted on
2024-05-16
Participant Flow
Participant milestones
| Measure |
Type 2 Diabetic
morbidly obese type 2 diabetic patients
|
Nondiabetic
morbidly obese nondiabetic patients
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
11
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
Reasons for withdrawal
| Measure |
Type 2 Diabetic
morbidly obese type 2 diabetic patients
|
Nondiabetic
morbidly obese nondiabetic patients
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
3
|
Baseline Characteristics
Erythrocyte and Adipocyte G6PD Activity Levels in Obesity
Baseline characteristics by cohort
| Measure |
Type 2 Diabetic
n=16 Participants
morbidly obese type 2 diabetic patients
|
Nondiabetic
n=11 Participants
morbidly obese nondiabetic patients
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.20 years
STANDARD_DEVIATION 2.52 • n=5 Participants
|
44 years
STANDARD_DEVIATION 3.40 • n=7 Participants
|
45.6 years
STANDARD_DEVIATION 2.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
body mass index
|
45.61 kilograms per meter squared
STANDARD_DEVIATION 2.61 • n=5 Participants
|
47.72 kilograms per meter squared
STANDARD_DEVIATION 2.92 • n=7 Participants
|
46.67 kilograms per meter squared
STANDARD_DEVIATION 2.77 • n=5 Participants
|
|
cholesterol
|
199.10 mg/dL
STANDARD_DEVIATION 12.23 • n=5 Participants
|
208.70 mg/dL
STANDARD_DEVIATION 11.90 • n=7 Participants
|
203.9 mg/dL
STANDARD_DEVIATION 12.07 • n=5 Participants
|
|
triglycerides
|
283.1 mg/dL
STANDARD_DEVIATION 56.25 • n=5 Participants
|
202.40 mg/dL
STANDARD_DEVIATION 43.61 • n=7 Participants
|
242.75 mg/dL
STANDARD_DEVIATION 49.93 • n=5 Participants
|
|
fasting insulin
|
54.89 mIU/L
STANDARD_DEVIATION 19.55 • n=5 Participants
|
36.49 mIU/L
STANDARD_DEVIATION 12.75 • n=7 Participants
|
45.69 mIU/L
STANDARD_DEVIATION 16.15 • n=5 Participants
|
|
homeostatic model assessment insulin resistent
|
30.51 HOMA-IR score
STANDARD_DEVIATION 11.98 • n=5 Participants
|
8.50 HOMA-IR score
STANDARD_DEVIATION 3.10 • n=7 Participants
|
19.51 HOMA-IR score
STANDARD_DEVIATION 7.54 • n=5 Participants
|
|
hemoglobin A 1 c
|
9.38 percent of HbA1c
STANDARD_DEVIATION 0.62 • n=5 Participants
|
5.52 percent of HbA1c
STANDARD_DEVIATION 0.06 • n=7 Participants
|
7.45 percent of HbA1c
STANDARD_DEVIATION 0.34 • n=5 Participants
|
|
fasting glucose
|
207 mg/dL
STANDARD_DEVIATION 17.69 • n=5 Participants
|
93.08 mg/dL
STANDARD_DEVIATION 2.50 • n=7 Participants
|
150.04 mg/dL
STANDARD_DEVIATION 10.10 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Diabetic
n=8 Participants
morbidly obese patients
|
Nondiabetic
n=8 Participants
nondiabetic morbidly obese
|
|---|---|---|
|
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
|
0.67 nM/min/mg
Standard Deviation 0.46
|
|
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
|
13 nM/min/mg
Standard Deviation 0.14
|
|
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
|
12 nM/min/mg
Standard Deviation 0.14
|
|
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
|
11.72 nM/min/mg
Standard Deviation 14.38
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Diabetic
n=16 Participants
morbidly obese patients
|
Nondiabetic
n=11 Participants
nondiabetic morbidly obese
|
|---|---|---|
|
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
|
0.67 nM/min/mg
Standard Error 0.14
|
|
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
|
13 nM/min/mg
Standard Error 2.8
|
|
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
|
12.5 nM/min/mg
Standard Error 2.7
|
|
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
|
4.9 nM/min/mg
Standard Error 1.5
|
SECONDARY outcome
Timeframe: time of gastric bypassOutcome measures
| Measure |
Diabetic
n=8 Participants
morbidly obese patients
|
Nondiabetic
n=8 Participants
nondiabetic morbidly obese
|
|---|---|---|
|
Measure Omentum G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass.
|
13 nM/min/mg
Standard Error 3
|
12 nM/min/mg
Standard Error 2
|
SECONDARY outcome
Timeframe: time of gastric bypassOutcome measures
| Measure |
Diabetic
n=8 Participants
morbidly obese patients
|
Nondiabetic
n=8 Participants
nondiabetic morbidly obese
|
|---|---|---|
|
Measure Hepatocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass.
|
17 nM/min/mg
Standard Error 2
|
11.9 nM/min/mg
Standard Error 2.1
|
Adverse Events
Type 2 Diabetic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nondiabetic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. William O. Richards
University of South Alabama, Department of Surgery
Phone: 251-471-7993
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place