Type 2 DiabetesEPCNCT01213940
Vascular Endothelium Changes After Bariatric Surgery (Endothelial Progenitor Cells)
A study testing pre-bariatric weight loss program and bariatric surgery in people with Type 2 Diabetes, run by University of South Alabama at 1 site in United States.
Trial summary
Improvement in cardiovascular mortality is related to changes in pathologic autoantibodies and in the number of circulating functional replicative competent endothelial progenitor cells (EPC's) after bariatric surgery. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- pre-bariatric weight loss program and bariatric surgery
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to May 2014
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes, Glucose > 200mg/dl, currently be ing treated with oral medications and HGA1c . 6.5, and BMI .35.
Who cannot join
- Type 1 Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vascular Endothelium Changes After Bariatric Surgery
Improvement in cardiovascular mortality is related to changes in pathologic autoantibodies and in the number of circulating functional replicative competent endothelial progenitor cells (EPC's) after bariatric surgery.
Read the detailed description
Same as above
- Conditions
- Type 2 Diabetes
- Being tested
- pre-bariatric weight loss program, bariatric surgery
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-bariatric weight loss programBehavioural
Also called weight loss program
standard 6 month physician directed pre-bariatric weight loss program
bariatric surgeryProcedure or surgery
bariatric surgery for weight loss
| Study group | Role | What they receive |
|---|---|---|
| baratric surgery | Other | surgery vs.weight loss program 6 months prior to bariatric surgery Receives: Procedure: bariatric surgery |
| pre-bariatric weight loss program | Other | weight loss program prior to bariatric surgery Receives: Behavioral: pre-bariatric weight loss program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Late Outgrowth Endothelial Progenitor Colonies
Primary outcome is the change in Late outgrowth endothelial progenitor colonies 12 months after enrollment to surgery (LRYGB) or to standard medical therapy (SMT).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionMay 2014
- Study completionMay 2014
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 Type 2 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Alabama
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Metabolic and Bariatric Surgery
- 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
- NCT01213940
- Sponsor's protocol ID
- 10-131
- Acronym
- EPC
- Status last verified
- May 2024
- First submitted
- 30 Sep 2010
- Last updated
- 9 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 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Endothelium Changes After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT01213940
- Acronym / sponsor ID
- EPC / 10-131
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of South AlabamaUniversity, hospital or other
- Collaborators
- American Society for Metabolic and Bariatric Surgery
- Study start
- Sep 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 4 Oct 2010 (estimated)
- Results
- Posted 14 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Improvement in cardiovascular mortality is related to changes in pathologic autoantibodies and in the number of circulating functional replicative competent endothelial progenitor cells (EPC's) after bariatric surgery.
Detailed description
Same as above
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| baratric surgery | Other | Procedure: bariatric surgerysurgery vs.weight loss program 6 months prior to bariatric surgery |
| pre-bariatric weight loss program | Other | Behavioral: pre-bariatric weight loss programweight loss program prior to bariatric surgery |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 Diabetes, Glucose > 200mg/dl, currently be ing treated with oral medications and HGA1c . 6.5, and BMI .35.
Key exclusion criteria (1 listed)
- Type 1 Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pre-bariatric weight loss programAlso: weight loss programstandard 6 month physician directed pre-bariatric weight loss program | Behavioural | pre-bariatric weight loss program |
| bariatric surgerybariatric surgery for weight loss | Procedure or surgery | baratric surgery |
Primary outcome
Change in Late Outgrowth Endothelial Progenitor Colonies
Time frame: 24 months
Primary outcome is the change in Late outgrowth endothelial progenitor colonies 12 months after enrollment to surgery (LRYGB) or to standard medical therapy (SMT).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pre-bariatric weight loss program and bariatric surgery in people with Type 2 Diabetes, run by University of South Alabama at 1 site 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 1 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 9 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 1 site 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 14 Dec 2020). 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?
Change in Late Outgrowth Endothelial Progenitor Colonies (time frame: 24 months). 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 9 May 2024.