DiabetesNCT01322035
Erythrocyte and Adipocyte G6PD Activity Levels in Obesity
An observational study of Diabetes and Obesity, run by University of South Alabama at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 to 70 years
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2009to Mar 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age > 19 years of age and <70 years of age
- HGA1c<6.0%
- fasting blood sugar less than 100mg/dL
Who cannot join
- Taking antidiabetic medications for other indications
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mobile Infirmary Medical Center
Mobile, Alabama, 36607
University of South Alabama
Mobile, Alabama, 36617
About this study
Official title: Erythrocyte and Adipocyte G6PD Activity Levels Correlate With Differing Degrees of Dyslipidemia, Insulin Resistance and Obesity
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).
Read the detailed description
Same as brief summary
- Medical subject headings
- Diabetes Mellitus, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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.
Measured: 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.
Measured: time of gastric bypass
Measure Hepatocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass.
Measured: time of gastric bypass
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startDec 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Alabama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Richards, University of South Alabama
- Investigators
- William O Richards, MD, Principal investigator, University of South Alabama, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322035
- Sponsor's protocol ID
- 09.0027
- Status last verified
- May 2024
- First submitted
- 23 Jun 2010
- Last updated
- 16 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erythrocyte and Adipocyte G6PD Activity Levels Correlate With Differing Degrees of Dyslipidemia, Insulin Resistance and Obesity
- ClinicalTrials.gov ID
- NCT01322035
- Acronym / sponsor ID
- 09.0027
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of South AlabamaUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 24 Mar 2011 (estimated)
- Results
- Posted 16 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age > 19 years of age and <70 years of age
- HGA1c<6.0%
- fasting blood sugar less than 100mg/dL
Key exclusion criteria (1 listed)
- Taking antidiabetic medications for other indications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure Erythrocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass.
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.
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.
3 secondary outcomes
Measure Adipocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass.
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.
Measure Omentum G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass.
Time frame: time of gastric bypass
Measure Hepatocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass.
Time frame: time of gastric bypass
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William O Richards, MD principal investigator
University of South Alabama, Department of Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Obesity, run by University of South Alabama at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure Erythrocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.