Diabetes MellitusNCT01481675
Diabetes Resolution and Hormone Changes After BPDLL and LSG
An observational study of Diabetes Mellitus, run by University of Patras at 2 sites in Greece.
Trial summary
To evaluate and compare prospectively the effects of Biliopancreatic Diversion Long Limb (BPDLL) and Laparoscopic Sleeve Gastrectomy (LSG) on resolution of diabetes mellitus type 2. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Diabetes Mellitus
- Type of treatment
- Pill or oral medicine
- How many people
- 24 participants
- Where
- 2 sitesGreece
- Study dates
- May 2007to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Twelve patients with diabetes mellitus type 2 and BMI> 50kg/m2 will undergo BPDLL and 12 patients with diabetes mellitus type 2 and BMI 40-50kg/m2 will undergo LSG
Who may be able to join
- BMI>50kg/m2 to undergo BPDLL
- BMI 40-50kg/m2 to undergo LSG
- Diabetes mellitus type 2
Who cannot join
- Chronic medical illness
- Psychiatric illness
- Substance abuse
- Previous gastrointestinal surgery
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
University Hospital of Patras
Rio, Achaia, 26500
University Hospital of Patras
Rio, Achaia, 26504
About this study
Official title: Resolution of Diabetes and Hormonal Changes Following Biliopancreatic Diversion Long Limbs and Laparoscopic Sleeve Gastrectomy. A Comparative Prospective Study.
To evaluate and compare prospectively the effects of Biliopancreatic Diversion Long Limb (BPDLL) and Laparoscopic Sleeve Gastrectomy (LSG) on resolution of diabetes mellitus type 2.
Read the detailed description
Twelve patients with diabetes mellitus type 2 (DM 2) and body mass index (BMI)> 50kg/m2) will undergo BPDLL and 12 twelve patients with DM 2 and BMI 40-50 kg/m2 will undergo LSG. The patients will be evaluated before and 1, 3 and 12 months after surgery with an oral glucose tolerance test. The investigators aim to investigate the effects of surgery on diabetes resolution, hypertension, dyslipidemia, and also on fasting, and glucose-stimulated insulin, glucagon, ghrelin, peptide-YY and glucagon-like peptide-1 (GLP-1) responses during during an oral glucose tolerance test (OGTT). Resolution of diabetes mellitus will be evaluated according to the criteria of American Diabetes Association with an OGTT. The effects on appetite and satiety will be also evaluated with the use of visual analog scores.
- Conditions
- Diabetes Mellitus
- Keywords
- biliopancreatic diversion, sleeve gastrectomy, diabetes mellitus, weight loss, ghrelin, PYY, GLP-1
- Medical subject headings
- Diabetes Mellitus, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BPDLL group | Patients subjected to the Biliopancreatic Diversion Long Limbs surgical operation will undergo an oral glucose tolerance preoperatively and 12 months after the operation | |
| LSG group | Patients subjected to laparoscopic sleeve gastrectomy will undergo an oral glucose tolerance test preoperatively and 12 months postoperatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes resolution at 12 months after surgery
Measured: 12 months after surgery
Secondary outcomes (4)
Weight loss at 12 months after surgery
Measured: 12 months after surgery
Changes of GLP-1 response to glucose
Measured: 12 months after surgery
Changes in ghrelin levels
Measured: 12 months after surgery
Changes in PYY response to glucose
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startMay 2007
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theodore K. Alexandrides, University of Patras
- Investigators
- Theodore Alexandrides, Professor, Principal investigator, University of PatrasFotis Kalfarentzos, Professor, Study director, University of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481675
- Sponsor's protocol ID
- BPDLSG002
- Other IDs
- BPDLL vs LSG
- Status last verified
- Nov 2011
- First submitted
- 24 Nov 2011
- Last updated
- 30 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resolution of Diabetes and Hormonal Changes Following Biliopancreatic Diversion Long Limbs and Laparoscopic Sleeve Gastrectomy. A Comparative Prospective Study.
- ClinicalTrials.gov ID
- NCT01481675
- Acronym / sponsor ID
- BPDLSG002
- Conditions
- Diabetes Mellitus
- Keywords
- biliopancreatic diversion, sleeve gastrectomy, diabetes mellitus, weight loss, ghrelin, PYY, GLP-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate and compare prospectively the effects of Biliopancreatic Diversion Long Limb (BPDLL) and Laparoscopic Sleeve Gastrectomy (LSG) on resolution of diabetes mellitus type 2.
Detailed description
Twelve patients with diabetes mellitus type 2 (DM 2) and body mass index (BMI)> 50kg/m2) will undergo BPDLL and 12 twelve patients with DM 2 and BMI 40-50 kg/m2 will undergo LSG. The patients will be evaluated before and 1, 3 and 12 months after surgery with an oral glucose tolerance test. The investigators aim to investigate the effects of surgery on diabetes resolution, hypertension, dyslipidemia, and also on fasting, and glucose-stimulated insulin, glucagon, ghrelin, peptide-YY and glucagon-like peptide-1 (GLP-1) responses during during an oral glucose tolerance test (OGTT). Resolution of diabetes mellitus will be evaluated according to the criteria of American Diabetes Association with an OGTT. The effects on appetite and satiety will be also evaluated with the use of visual analog scores.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPDLL group | – | –Patients subjected to the Biliopancreatic Diversion Long Limbs surgical operation will undergo an oral glucose tolerance preoperatively and 12 months after the operation |
| LSG group | – | –Patients subjected to laparoscopic sleeve gastrectomy will undergo an oral glucose tolerance test preoperatively and 12 months postoperatively |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Twelve patients with diabetes mellitus type 2 and BMI> 50kg/m2 will undergo BPDLL and 12 patients with diabetes mellitus type 2 and BMI 40-50kg/m2 will undergo LSG
Key inclusion criteria (3 listed)
- BMI>50kg/m2 to undergo BPDLL
- BMI 40-50kg/m2 to undergo LSG
- Diabetes mellitus type 2
Key exclusion criteria (4 listed)
- Chronic medical illness
- Psychiatric illness
- Substance abuse
- Previous gastrointestinal surgery
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
Diabetes resolution at 12 months after surgery
Time frame: 12 months after surgery
4 secondary outcomes
Weight loss at 12 months after surgery
Time frame: 12 months after surgery
Changes of GLP-1 response to glucose
Time frame: 12 months after surgery
Changes in ghrelin levels
Time frame: 12 months after surgery
Changes in PYY response to glucose
Time frame: 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2011.
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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.
Theodore Alexandrides, Professor principal investigator
University of Patras
Fotis Kalfarentzos, Professor study director
University of Patras
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 Mellitus, run by University of Patras at 2 sites in Greece.
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 4 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 30 Nov 2011. 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 Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diabetes resolution at 12 months after surgery (time frame: 12 months after 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 30 Nov 2011; AzTrials last refreshed its copy on 31 Oct 2026.