HypoglycemiaNCT00998374
Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge
An observational study of Hypoglycemia and Obesity, run by Medtronic - MITG at 1 site in United States.
Trial summary
This study will compare glucose and simple carbohydrate sensitivity. The hypothesis is that rapid emptying of high-glycemic index foods after Roux-En-Y gastric bypass (RYGB) causes reactive hypoglycemia. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypoglycemia, Obesity
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Apr 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients >18 years of age BMI greater than or equal to 35
Who may be able to join
- The patient is greater than 18 years old;
- The patient has a BMI > 35;
- Patient meets standards for bariatric surgery;
Who cannot join
- The patient has an incurable malignant or debilitating disease;
- The patient has been diagnosed with a severe eating disorder;
- The patient is currently pregnant (pregnancy test required for confirmation for those of child bearing years);
- The patient is unable to comply with the study requirements, follow-up schedule, or to give valid informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Lenox Hill Hospital 186 E76th Street, 1st Floor
New York, New York, 10021
About this study
This study will compare glucose and simple carbohydrate sensitivity. The hypothesis is that rapid emptying of high-glycemic index foods after Roux-En-Y gastric bypass (RYGB) causes reactive hypoglycemia. It is believed that the controlled release offered by an intact pylorus will be advantageous for long term results in bariatric surgery. This study can provide a scientific rationale, in a short duration of time, for why pylorus sparing surgery, such as the sleeve gastrectomy or duodenal switch, may offer therapeutic advantages, as compared to non-pyloric sparing surgery, namely the gastric bypass.
Read the detailed description
Clinical Trial Objective:
The objective of this clinical trial is to determine whether an intact pylorus prevents reactive hypoglycemia following challenge with liquid glucose preparation and/or solid load made of refined flour product that is a simple carbohydrate.
Clinical Trial Design:
This is a prospective, non-randomized, clinical trial.
- Conditions
- Hypoglycemia, Obesity
- Medical subject headings
- Hypoglycemia, Obesity
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 |
|---|---|---|
| Pyloric-sparing vs. non-pyloric sparing | Pyloric: SG \& DS Non-pyloric: RYGB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Serum Glucose Levels
Serum glucose levels measured to assess reactive hypoglycemia status
Measured: 30, 60, and 120 minutes at 6, 9, and 12 months post-operatively
Reactive Hypoglycemia Status
Postoperative reactive hypoglycemia was defined as either
- serum glucose <60 mg/dL at least 1 hour after initiation of glucose tolerance testing
- serum glucose decrease ≥100 mg/dL within 1 hour after initiation of glucose tolerance testing
Measured: 6 months, 9 months, 12 months post-op
Secondary outcomes (2)
Insulin Resistance
Measured by levels of post prandial insulin
Measured: 6, 9, and 12 months post-operatively
Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing
Subjective symptoms of hypoglycemia during glucose tolerance testing measured by patients' responses to a questionnaire about symptoms of Weakness, Nausea, Hunger, Headache, Dizziness, Diaphoresis graded on a yes/no response
Measured: 6, 9, and 12 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2013
- Study completionApr 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 HypoglycemiaStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitchell Roslin, MD, Principal investigator, Lenox Hill Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998374
- Sponsor's protocol ID
- AS08018
- Status last verified
- Mar 2014
- First submitted
- 15 Oct 2009
- Last updated
- 21 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge
- ClinicalTrials.gov ID
- NCT00998374
- Acronym / sponsor ID
- AS08018
- Conditions
- Hypoglycemia, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 20 Oct 2009 (estimated)
- Results
- Posted 21 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare glucose and simple carbohydrate sensitivity. The hypothesis is that rapid emptying of high-glycemic index foods after Roux-En-Y gastric bypass (RYGB) causes reactive hypoglycemia. It is believed that the controlled release offered by an intact pylorus will be advantageous for long term results in bariatric surgery. This study can provide a scientific rationale, in a short duration of time, for why pylorus sparing surgery, such as the sleeve gastrectomy or duodenal switch, may offer therapeutic advantages, as compared to non-pyloric sparing surgery, namely the gastric bypass.
Detailed description
Clinical Trial Objective:
The objective of this clinical trial is to determine whether an intact pylorus prevents reactive hypoglycemia following challenge with liquid glucose preparation and/or solid load made of refined flour product that is a simple carbohydrate.
Clinical Trial Design:
This is a prospective, non-randomized, clinical trial.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pyloric-sparing vs. non-pyloric sparing | – | –Pyloric: SG \& DS Non-pyloric: RYGB |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients >18 years of age BMI greater than or equal to 35
Key inclusion criteria (3 listed)
- The patient is greater than 18 years old;
- The patient has a BMI > 35;
- Patient meets standards for bariatric surgery;
Key exclusion criteria (4 listed)
- The patient has an incurable malignant or debilitating disease;
- The patient has been diagnosed with a severe eating disorder;
- The patient is currently pregnant (pregnancy test required for confirmation for those of child bearing years);
- The patient is unable to comply with the study requirements, follow-up schedule, or to give valid informed consent
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
Mean Serum Glucose Levels
Time frame: 30, 60, and 120 minutes at 6, 9, and 12 months post-operatively
Serum glucose levels measured to assess reactive hypoglycemia status
Reactive Hypoglycemia Status
Time frame: 6 months, 9 months, 12 months post-op
Postoperative reactive hypoglycemia was defined as either * serum glucose <60 mg/dL at least 1 hour after initiation of glucose tolerance testing * serum glucose decrease ≥100 mg/dL within 1 hour after initiation of glucose tolerance testing
2 secondary outcomes
Insulin Resistance
Time frame: 6, 9, and 12 months post-operatively
Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing
Time frame: 6, 9, and 12 months post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
- 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.
Mitchell Roslin, MD principal investigator
Lenox Hill Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoglycemia and Obesity, run by Medtronic - MITG 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 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 21 Apr 2014. 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 21 Apr 2014). 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?
Mean Serum Glucose Levels (time frame: 30, 60, and 120 minutes at 6, 9, and 12 months post-operatively). The study lists 2 primary outcomes in all. 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 21 Apr 2014.