DiabetesPhase 1MIDASNCT00488423
Glucose Metabolism in the Immediate and Short Term Follow up After Bariatric Surgery
A Phase 1 study testing Mixed Meal Tolerance test, Hyperglycemic clamp in people with Diabetes and Gastric Bypass, run by The Cleveland Clinic at 1 site in United States.
Trial summary
MIDAS involves an assessment of glucose levels obtained before and after bariatric surgery. There are two different procedural tests involved; an oral glucose tolerance test (mixed meal) and a hyperglycemic clamp test. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Diabetes, Gastric Bypass
- What is being tested?
- Mixed Meal Tolerance test, Hyperglycemic clamp
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Nov 2008
- Phase
- Phase 1
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Negative pregnancy test if female
- ADA criteria for diabetes type II
- Hematocrit > 35 creatinine < 1.9, AST < 3X upper limit of normal, ALT < 3X upper limit of normal, alkaline phos <3X upper limit of normal
- Eligibility for bariatric surgery based on the NIH and clinical criteria
- Mentally and legally capable of providing consent
Who cannot join
- Lactating females
- Must not have type I diabetes
- Systemic steroids taken within 6 months
- Clinically significant heart disease
- Recent pulmonary embolism, untreated proliferative retinopathy, renal failure, uncontrolled hypertension, autonomic neuropathy, resting heart rate > 100, neuromuscular or musculoskeletal disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glucose Metabolism in the Immediate and Short Term Follow up From Bariatric Surgery
MIDAS involves an assessment of glucose levels obtained before and after bariatric surgery. There are two different procedural tests involved; an oral glucose tolerance test (mixed meal) and a hyperglycemic clamp test. Two tests are performed preoperatively and five more are performed postoperatively for a one year period. The associated labwork drawn with the mixed meal and clamp tests are demonstrating changes in glucose, insulin and gut hormone levels.
Read the detailed description
Tests performed are the Mixed Meal tolerance test, the Hyperglycemic Clamp test, c-peptide, free fatty acids, adipocyte hormone profile levels.
- Conditions
- Diabetes, Gastric Bypass
- Being tested
- Mixed Meal Tolerance test, Hyperglycemic clamp
- Keywords
- diabetes, MIDAS, gut hormones, gastric bypass, lap band
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed Meal Tolerance test, Hyperglycemic clampProcedure or surgery
Also called MMTT
Subjects undergo a standard mixed meal tolerance test \& hyperglycemic clamp to assess insulin secretion \& sensitivity (whole body glucose disposal) pre-op. Following surgery, at 1week, 1 month, 6 months and 12 months subjects will undergo hyperglycemic clamp \& mixed meal tolerance test. During these tests, measurements will include plasma levels of glucose, insulin, C-peptide, free fatty acid levels and adipocyte hormone profile (adiponectin, leptin, resistin). A gut hormone profile (ghrelin, glucagons-like-peptide 1 GLP-1, glucose-dependent insulinotropic polypeptide GIP, PYY) will be performed at fasting \& specific postprandial times. Results will be compared between two groups: patients undergoing laparoscopic Roux-en-Y gastric bypass \& gastric banding.
| Study group | Role | What they receive |
|---|---|---|
| Lap-band | Active comparator | Patient undergoing Lap-band Bariatric Surgery Receives: Procedure: Mixed Meal Tolerance test, Hyperglycemic clamp |
| Gastric Bypass | Active comparator | Patient's undergoing Laparoscopic Roux-N Y Gastric Bypass surgery. Receives: Procedure: Mixed Meal Tolerance test, Hyperglycemic clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of gastric by-pass surgery to decrease lipotoxicity.
Measured: One year
Secondary outcomes (1)
To examine the effect of roux-en-Y compared to gastric banding on pancreatic B cell recovery or insulin secretion in response to oral and IV glucose.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startNov 2006
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Interventional
- Phase
- Phase 1
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Investigators
- Sangeeta R. Kashyap, MD, Principal investigator, The Cleveland ClinicPhilip R. Schauer, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488423
- Sponsor's protocol ID
- 8585
- Acronym
- MIDAS
- Status last verified
- Jun 2011
- First submitted
- 18 Jun 2007
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Metabolism in the Immediate and Short Term Follow up From Bariatric Surgery
- ClinicalTrials.gov ID
- NCT00488423
- Acronym / sponsor ID
- MIDAS / 8585
- Conditions
- Diabetes, Gastric Bypass
- Keywords
- diabetes, MIDAS, gut hormones, gastric bypass, lap band
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Study start
- Nov 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 20 Jun 2007 (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.
MIDAS involves an assessment of glucose levels obtained before and after bariatric surgery. There are two different procedural tests involved; an oral glucose tolerance test (mixed meal) and a hyperglycemic clamp test. Two tests are performed preoperatively and five more are performed postoperatively for a one year period. The associated labwork drawn with the mixed meal and clamp tests are demonstrating changes in glucose, insulin and gut hormone levels.
Detailed description
Tests performed are the Mixed Meal tolerance test, the Hyperglycemic Clamp test, c-peptide, free fatty acids, adipocyte hormone profile levels.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lap-band | Active comparator | Procedure: Mixed Meal Tolerance test, Hyperglycemic clampPatient undergoing Lap-band Bariatric Surgery |
| Gastric Bypass | Active comparator | Procedure: Mixed Meal Tolerance test, Hyperglycemic clampPatient's undergoing Laparoscopic Roux-N Y Gastric Bypass surgery. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Negative pregnancy test if female
- ADA criteria for diabetes type II
- Hematocrit > 35 creatinine < 1.9, AST < 3X upper limit of normal, ALT < 3X upper limit of normal, alkaline phos <3X upper limit of normal
- Eligibility for bariatric surgery based on the NIH and clinical criteria
- Mentally and legally capable of providing consent
Key exclusion criteria (5 listed)
- Lactating females
- Must not have type I diabetes
- Systemic steroids taken within 6 months
- Clinically significant heart disease
- Recent pulmonary embolism, untreated proliferative retinopathy, renal failure, uncontrolled hypertension, autonomic neuropathy, resting heart rate > 100, neuromuscular or musculoskeletal disease.
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 |
|---|---|---|
| Mixed Meal Tolerance test, Hyperglycemic clampAlso: MMTTSubjects undergo a standard mixed meal tolerance test \& hyperglycemic clamp to assess insulin secretion \& sensitivity (whole body glucose disposal) pre-op. Following surgery, at 1week, 1 month, 6 months and 12 months subjects will undergo hyperglycemic clamp \& mixed meal tolerance test. During these tests, measurements will include plasma levels of glucose, insulin, C-peptide, free fatty acid levels and adipocyte hormone profile (adiponectin, leptin, resistin). A gut hormone profile (ghrelin, glucagons-like-peptide 1 GLP-1, glucose-dependent insulinotropic polypeptide GIP, PYY) will be performed at fasting \& specific postprandial times. Results will be compared between two groups: patients undergoing laparoscopic Roux-en-Y gastric bypass \& gastric banding. | Procedure or surgery | Gastric Bypass, Lap-band |
Primary outcome
To assess the effect of gastric by-pass surgery to decrease lipotoxicity.
Time frame: One year
1 secondary outcome
To examine the effect of roux-en-Y compared to gastric banding on pancreatic B cell recovery or insulin secretion in response to oral and IV glucose.
Time frame: One Year
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 22 Jun 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.
Sangeeta R. Kashyap, MD principal investigator
The Cleveland Clinic
Philip R. Schauer, M.D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mixed Meal Tolerance test, Hyperglycemic clamp in people with Diabetes and Gastric Bypass, run by The Cleveland Clinic 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 5 inclusion and 5 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 22 Jun 2011. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To assess the effect of gastric by-pass surgery to decrease lipotoxicity. (time frame: One year). 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 22 Jun 2011.