Erythrocyte and Adipocyte G6PD Activity Levels in Obesity

NCT01322035 | Completed Results

• 1 other identifier: 09.0027
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 2

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).

Conditions

Diabetes; Obesity

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• 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.

• 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

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Age \> 19 years of age and \<70 years of age
• HGA1c\<6.0%
• fasting blood sugar less than 100mg/dL

You may not qualify if:

• Taking antidiabetic medications for other indications

Sponsors & Collaborators

• University of South Alabama: lead

Study Sites (2)

Mobile Infirmary Medical Center

Mobile, Alabama, 36607, United States

Location

University of South Alabama

Mobile, Alabama, 36617, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and tissue samples(adipose, omentum and liver biopsies)

MeSH Terms

Conditions

Diabetes Mellitus; Obesity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. William O. Richards
• Organization: University of South Alabama, Department of Surgery

brichards@health.southalabama.edu

251-471-7993

Study Officials

• William O Richards, MD

  University of South Alabama, Department of Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 23, 2010
• First Posted: March 24, 2011
• Study Start: December 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: May 16, 2024
• Results First Posted: May 16, 2024

Record last verified: 2024-05

Locations

US (2)