Type 2 Diabetes MellitusNCT01197963
A Surgical Approach to the Management of Type II Diabetes Mellitus in Patients With a BMI Between 25-35 kg/m2
A study testing Sleeve Gastrectomy and Ileal transposition and dietary and medical management in people with Type 2 Diabetes Mellitus, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of the study is to determine if by performing surgery we can cure Type II Diabetes. The surgical procedures: 1. a sleeve gastrectomy, cutting out a portion of the stomach, which provides restriction of caloric intake and rapid gastric emptying. 2. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Sleeve Gastrectomy and Ileal transposition and dietary and medical management
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Feb 2014
- Phase
- Interventional
- 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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age- 21-55 years.
- Body Mass Index between 25-35 kf/m2.
- currently being treated for type 2 diabetes mellitus with oral hypoglycemic, insulin or both for the at least 3 years.
- Documented HbA1c>7.5% for at least 3 months.
- Stable weight for 3 months (+/-)
- Evidence of stable medical treatment for diabetes over the past 12 months.
- Able to provide informed consent -Female subject agrees to participate in accepted birth control methods -
Who cannot join
- Type I diabetes/juvenile onset
- C-Peptid levels below 1.0 ng/ml
- Previous major upper abdominal surgery
- --Pregnant or plans to become pregnant with in the next 12 months
- Current Malignancy
- Severe pulmonary, cardia, or renal disease
Show all 14Show fewer
- Eating disorders such as bulimia or binge-eating
- Severe mental health disorders such as schizophrenia and bipolar disorder
- Obesity due to other metabolic disorders
- taking appetite suppressants
- currently abusing illicit drugs,alcohol or using tobacco products
- Unable to provide informed consent
- Unwillingness or unable to comply with study procedures
- any condition that deems them unsuitable for the study in the opinion of the investigators
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to determine if by performing surgery we can cure Type II Diabetes.
The surgical procedures:
- a sleeve gastrectomy, cutting out a portion of the stomach, which provides restriction of caloric intake and rapid gastric emptying.
- ileal transposition which involves repositioning a 150cm segment of the ileum into the jejunum causing improved glucose homeostasis.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Sleeve Gastrectomy and Ileal transposition, dietary and medical management
- Keywords
- Type 2 diabetes mellitus
- 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.
Sleeve Gastrectomy and Ileal transpositionProcedure or surgery
Laparoscopic sleeve gastrectomy with ileal transposition
dietary and medical managementDietary supplement
dietary and medical routine management patients are currently following with an endocrinologist.
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment | Other | Surgical treatment of one arm of the patient population. Receives: Procedure: Sleeve Gastrectomy and Ileal transposition |
| Medically controlled group | Other | Managed by endocrinologists using current medical therapy such as pills, injections and life style medication. Receives: Dietary Supplement: dietary and medical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serial Postoperative HgA1c levels
Effectiveness of the transposition to alleviate hyperglycemia will be measured by following serial post operative HbA1c levels. The change from baseline mearusements will be used to determine the outcome. Type 2 diabetes is considered resolved if there is normalization of fasting glucose(<110 mg/dl) normal HbA1c (<6%) and no need for diabetic medications.
Measured: 1 month intervals for 3 months then every 3 months there after
Secondary outcomes (1)
Serial Postoperative Lipid Profiles levels
Lipid profiles will be examined at follow up witha goal of total cholesterol <200 mg/dl, low-density lipoprotein (LDL) levels <100 mg/dl, triglyceride levels <150 mg/dl, and high-density lipoprotein (HDL) levels >40 mg/dl. Patients will be fasting for 8 hours and the serum glucose and GLP-1 level will be checked.
Measured: 1 month for the first 3 months then every 3 months there after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: IRB temporarily halted enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brad Snyder, The University of Texas Health Science Center, Houston
- Investigators
- Brad E Snyder, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197963
- Sponsor's protocol ID
- HSC-MS-09-0122
- Status last verified
- Jun 2015
- First submitted
- 7 Sep 2010
- Last updated
- 12 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Surgical Approach to the Management of Type II Diabetes Mellitus in Patients With a BMI Between 25-35 kg/m2
- ClinicalTrials.gov ID
- NCT01197963
- Acronym / sponsor ID
- HSC-MS-09-0122
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 diabetes mellitus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB temporarily halted enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 9 Sep 2010 (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.
The purpose of the study is to determine if by performing surgery we can cure Type II Diabetes.
The surgical procedures:
- a sleeve gastrectomy, cutting out a portion of the stomach, which provides restriction of caloric intake and rapid gastric emptying.
- ileal transposition which involves repositioning a 150cm segment of the ileum into the jejunum causing improved glucose homeostasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment | Other | Procedure: Sleeve Gastrectomy and Ileal transpositionSurgical treatment of one arm of the patient population. |
| Medically controlled group | Other | Dietary Supplement: dietary and medical managementManaged by endocrinologists using current medical therapy such as pills, injections and life style medication. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- age- 21-55 years.
- Body Mass Index between 25-35 kf/m2.
- currently being treated for type 2 diabetes mellitus with oral hypoglycemic, insulin or both for the at least 3 years.
- Documented HbA1c>7.5% for at least 3 months.
- Stable weight for 3 months (+/-)
Key exclusion criteria (14 listed)
- Type I diabetes/juvenile onset
- C-Peptid levels below 1.0 ng/ml
- Previous major upper abdominal surgery
- --Pregnant or plans to become pregnant with in the next 12 months
- Current Malignancy
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 |
|---|---|---|
| Sleeve Gastrectomy and Ileal transpositionLaparoscopic sleeve gastrectomy with ileal transposition | Procedure or surgery | Surgical treatment |
| dietary and medical managementdietary and medical routine management patients are currently following with an endocrinologist. | Dietary supplement | Medically controlled group |
Primary outcome
Serial Postoperative HgA1c levels
Time frame: 1 month intervals for 3 months then every 3 months there after
Effectiveness of the transposition to alleviate hyperglycemia will be measured by following serial post operative HbA1c levels. The change from baseline mearusements will be used to determine the outcome. Type 2 diabetes is considered resolved if there is normalization of fasting glucose(<110 mg/dl) normal HbA1c (<6%) and no need for diabetic medications.
1 secondary outcome
Serial Postoperative Lipid Profiles levels
Time frame: 1 month for the first 3 months then every 3 months there after
Results and safety
The study was stopped early (reason given: IRB temporarily halted enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2015.
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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.
Brad E Snyder, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleeve Gastrectomy and Ileal transposition and dietary and medical management in people with Type 2 Diabetes Mellitus, run by The University of Texas Health Science Center, Houston 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 7 inclusion and 14 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: stopped early, as of the sponsor's last update on 12 Jun 2015. 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?
The study was stopped early (reason given: IRB temporarily halted enrollment). Results are not available in the source record.
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?
Serial Postoperative HgA1c levels (time frame: 1 month intervals for 3 months then every 3 months there after). 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 12 Jun 2015.