Type 2 DiabetesNCT01771185
Metabolic Effects of Gastrointestinal Surgery in T2DM
A study testing Duodenal jejunal bypass plus sleeve gastrectomy and Best medical treatment (Metformin ; gliclazide) in people with Type 2 Diabetes, run by University of Sao Paulo.
Trial summary
Gastric bypass surgery resolves type 2 diabetes mellitus (T2DM) without the need for diabetes therapy in ~80% of patients. Moreover, improvement in insulin sensitivity and glucose homeostasis occurs within days after surgery before significant weight loss is achieved. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Duodenal jejunal bypass plus sleeve gastrectomy and Best medical treatment (Metformin ; gliclazide)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Dec 2013
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Uncontrolled diabetes ( A1c>8%)
- Less than 10 years of history
- Not taking insulin
- Ages between 20 and 65 years old
- BMI between 26-34
Who cannot join
- previous abdominal surgery
- LADA
- Using insulin
About this study
Official title: Metabolic Effects of Duodenal-jejunal Bypass Surgery in Non Morbidly Obese Subjects With Type 2 Diabetes
Gastric bypass surgery resolves type 2 diabetes mellitus (T2DM) without the need for diabetes therapy in ~80% of patients. Moreover, improvement in insulin sensitivity and glucose homeostasis occurs within days after surgery before significant weight loss is achieved. This observation has led to the notion that bypassing the upper gastrointestinal (GI) tract has specific therapeutic effects on insulin action and glucose metabolism. In fact, both surgical and endoscopic procedures that bypass the upper GI tract are currently being studied in human subjects. Recently, a new surgical technique, duodenal-jejunal bypass surgery (DJBS), has been developed specifically to treat T2DM. Data from preliminary studies have shown that DJBS results in glycemic control in 87% of overweight and obese patients with T2DM.These subjects will undergo metabolic studies at the University Hospital in Sao Paulo before and after their surgical procedure. Washington University investigators will: 1) provide technical support and guidance to the physicians performing the studies in Brazil, 2) process and analyze blood samples obtained from the study at the Washington University Center for Human Nutrition, and 3) be involved in analyzing the data and writing the final manuscripts. The effects of DJBS on the following clinical and metabolic parameters will be evaluated
- Conditions
- Type 2 Diabetes
- Being tested
- Duodenal jejunal bypass plus sleeve gastrectomy, Best medical treatment (Metformin ; gliclazide)
- Keywords
- Diabetes, metabolic surgery, insulin resistance
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duodenal jejunal bypass plus sleeve gastrectomyProcedure or surgery
Metabolic Surgery Duodenal jejunal bypass plus sleeve gastrectomy
Best medical treatment (Metformin ; gliclazide)Drug
Metformin 2 g/day; gliclazide 30 mg
| Study group | Role | What they receive |
|---|---|---|
| Best medical treatment | Active comparator | Metformin 2 g/day; gliclazide 30 mg Receives: Drug: Best medical treatment (Metformin ; gliclazide) |
| Duodenal jejunal bypass plus sleeve gastrectomy | Active comparator | Duodenal jejunal bypass plus sleeve gastrectomy is a metabolic surgical procedure Receives: Procedure: Duodenal jejunal bypass plus sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hb A1a
Primary endpoints- glycemic control
Measured: 24 mo
Secondary outcomes (3)
Systolic and diastolic blood pressure control
Measured: 24 mo
fasting glycemic control
Measured: 24 months
Lipidic control
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 posted18 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionOct 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Cohen, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771185
- Sponsor's protocol ID
- HUUSP001
- Status last verified
- Jan 2013
- First submitted
- 14 Jan 2013
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Duodenal-jejunal Bypass Surgery in Non Morbidly Obese Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01771185
- Acronym / sponsor ID
- HUUSP001
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, metabolic surgery, insulin resistance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 18 Jan 2013 (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.
Gastric bypass surgery resolves type 2 diabetes mellitus (T2DM) without the need for diabetes therapy in ~80% of patients. Moreover, improvement in insulin sensitivity and glucose homeostasis occurs within days after surgery before significant weight loss is achieved. This observation has led to the notion that bypassing the upper gastrointestinal (GI) tract has specific therapeutic effects on insulin action and glucose metabolism. In fact, both surgical and endoscopic procedures that bypass the upper GI tract are currently being studied in human subjects. Recently, a new surgical technique, duodenal-jejunal bypass surgery (DJBS), has been developed specifically to treat T2DM. Data from preliminary studies have shown that DJBS results in glycemic control in 87% of overweight and obese patients with T2DM.These subjects will undergo metabolic studies at the University Hospital in Sao Paulo before and after their surgical procedure. Washington University investigators will: 1) provide technical support and guidance to the physicians performing the studies in Brazil, 2) process and analyze blood samples obtained from the study at the Washington University Center for Human Nutrition, and 3) be involved in analyzing the data and writing the final manuscripts. The effects of DJBS on the following clinical and metabolic parameters will be evaluated
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best medical treatment | Active comparator | Drug: Best medical treatment (Metformin ; gliclazide)Metformin 2 g/day; gliclazide 30 mg |
| Duodenal jejunal bypass plus sleeve gastrectomy | Active comparator | Procedure: Duodenal jejunal bypass plus sleeve gastrectomyDuodenal jejunal bypass plus sleeve gastrectomy is a metabolic surgical procedure |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Uncontrolled diabetes ( A1c>8%)
- Less than 10 years of history
- Not taking insulin
- Ages between 20 and 65 years old
- BMI between 26-34
Key exclusion criteria (3 listed)
- previous abdominal surgery
- LADA
- Using insulin
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 |
|---|---|---|
| Duodenal jejunal bypass plus sleeve gastrectomyMetabolic Surgery Duodenal jejunal bypass plus sleeve gastrectomy | Procedure or surgery | Duodenal jejunal bypass plus sleeve gastrectomy |
| Best medical treatment (Metformin ; gliclazide)Metformin 2 g/day; gliclazide 30 mg | Drug | Best medical treatment |
Primary outcome
Hb A1a
Time frame: 24 mo
Primary endpoints- glycemic control
3 secondary outcomes
Systolic and diastolic blood pressure control
Time frame: 24 mo
fasting glycemic control
Time frame: 24 months
Lipidic control
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Duodenal jejunal bypass plus sleeve gastrectomy and Best medical treatment (Metformin ; gliclazide) in people with Type 2 Diabetes, run by University of Sao Paulo.
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 3 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: status not confirmed, as of the sponsor's last update on 18 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Hb A1a (time frame: 24 mo). 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 18 Jan 2013.