Type 2 Diabetes MellitusDJBNCT00562029
Study of Duodenal-Jejunal Bypass(DJB) as a Potential Cure for Type 2 Diabetes Mellitus
A study testing Duodenal-jejunal Bypass in people with Type 2 Diabetes Mellitus, run by Sound Shore Medical Center of Westchester at 1 site in United States.
Trial summary
Premise: Complete resolution of Type 2 Diabetes Mellitus with normalization of blood glucose and HbA1c in the abscence of medication support is possible with a surgical procedure named the "Duodenal-Jejunal Bypass (DJB)" a modification of an established duodenal switch procedure and is performed utilizing the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Duodenal-jejunal Bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Dec 2011
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established diagnosis of Type 2 diabetes mellitus
- Body Mass Index(BMI) less than 35
- Insulin usage duration less than 10 years
- Negative anti-GAD
- Fasting C-peptide level over 1.0 mcg/ml
- Ability and willingness to follow up for a period of 1 year
- Willingness to consent for utilizing personal results without individual identifier information to be published in medical studies and other media as determined by the study investigators
- Ability to understand and describe the risks, benefits and mechanism of action of the procedure
Who cannot join
- Current pregnancy or positive pregnancy test
- Liver Cirrhosis
- Coagulopathy
- Type 1 Diabetes Mellitus
- HIV
- Previous abdominal surgery preventing laparoscopy
Show all 15Show fewer
- Previous vagotomy
- Previous gastric or small intestine surgery
- Inability to comply with study requirements
- Currently active medical malpractice lawsuit/s
- Diseases of the exocrine pancreas: pancreatitis trauma, pancreatectomy, neoplasia, cystic fibrosis, hemochromatosis
- Endocrinopathies: acromegaly, glucagonoma, Cushing's Syndrome, pheochromocytoma, hyperthyroidism, somatostatinoma, aldorestanoma
- Chemical Induced Diabetes: vacor, pentamidine, nicotinic acid, glucocorticoids, thyroid hormones, diazoxide, beta-adrenergic agonists, thiazides, phenytoin, alfa-interferon
- Genetic Syndromes with Diabetes: Down's, Klinefelter's, Turner's, Wolfram, Lawrence-Moon- Beidel, Prader-Willi, Friederich's ataxia, Huntington's Chorea, Myotonic Dystrophy, Porphyria,
- If a candidate is deemed to be not an appropriate candidate based on investigators recommendation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sound Shore Medical Center of Westchester
New Rochelle, New York, 10802
About this study
Official title: Modified Duodenal Switch Procedure "Duodenal-Jejunal Bypass" (Diabetes Surgery) As A Potential Cure for Type 2 Diabetes Mellitus in Non-Obese Patients- a Pilot Project to Validate a Prospective Randomized Control Trial
Premise: Complete resolution of Type 2 Diabetes Mellitus with normalization of blood glucose and HbA1c in the abscence of medication support is possible with a surgical procedure named the "Duodenal-Jejunal Bypass (DJB)" a modification of an established duodenal switch procedure and is performed utilizing the laparoscopic approach.
Read the detailed description
Hypothesis: The duodenum plays a major role in glucose homeostasis through mechanisms largely unknown at this time. Evidence of this hypothesis comes from accumulated data in bariatric surgery patients who underwent Roux-en-y Gastric Bypass or Biliopancreatic Diversion (BPD) with or without a Duodenal Switch. Current evidence strongly supports this hypothesis with a long term (over 10 years) Type 2 Diabetes Mellitus(T2DM) resolution rate of 84-86% following the gastric bypass and over 95% for the duodenal switch.
The clinical resolution of T2DM is defined as independence of all anti-diabetic medications and maintaining a HbA1c less than 6.0. Recent rodent experiments by Francesco Rubino and subsequent human case reports by Cohen et al. supports the validity of this hypothesis. The modified procedure involved a roux-en-y bypass of the duodenum and 30-50cm of proximal jejunum, unaltering the stomach and pylorus resulted in resolution of T2DM with no weight loss in all subjects.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Duodenal-jejunal Bypass
- Keywords
- Diabetes Mellitus, Surgery, Duodenal Bypass, Resolution, Surgical Procedures
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duodenal-jejunal BypassProcedure or surgery
Patient has undergone a duodenal bypass and bypass of 60cm of proximal jejunum
| Study group | Role | What they receive |
|---|---|---|
| DJB patient | Experimental | Patient has undergone a duodeno-jejunal bypass Receives: Procedure: Duodenal-jejunal Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: Resolution of Type 2 Diabetes Mellitus
Measured: One year
Secondary outcomes (1)
Measure: Safety and efficacy of duodenal-jejunal bypass
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 posted21 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sound Shore Medical Center of Westchester
- Sponsor type
- University, hospital or other
- Collaborators
- Maffucci L, Rangraj M
- Responsible party
- Sponsor
- Investigators
- Leonard Maffucci, MD, Principal investigator, Sound Shore Medical Center of WestchesterMadhu S Rangraj, MD, Principal investigator, Sound Shore Medical Center of Westchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562029
- Sponsor's protocol ID
- djb-2007
- Acronym
- DJB
- Status last verified
- May 2015
- First submitted
- 19 Nov 2007
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rubino F, Forgione A, Cummings DE, Vix M, Gnuli D, Mingrone G, Castagneto M, Marescaux J. The mechanism of diabetes control after gastrointestinal bypass surgery reveals a role of the proximal small intestine in the pathophysiology of type 2 diabetes. Ann Surg. 2006 Nov;244(5):741-9. doi: 10.1097/01.sla.0000224726.61448.1b.
PubMed 17060767Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.
PubMed 15479938Cummings DE, Overduin J, Foster-Schubert KE, Carlson MJ. Role of the bypassed proximal intestine in the anti-diabetic effects of bariatric surgery. Surg Obes Relat Dis. 2007 Mar-Apr;3(2):109-15. doi: 10.1016/j.soard.2007.02.003. No abstract available.
PubMed 17386391Cohen RV, Schiavon CA, Pinheiro JS, Correa JL, Rubino F. Duodenal-jejunal bypass for the treatment of type 2 diabetes in patients with body mass index of 22-34 kg/m2: a report of 2 cases. Surg Obes Relat Dis. 2007 Mar-Apr;3(2):195-7. doi: 10.1016/j.soard.2007.01.009. No abstract available.
PubMed 17386401
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Duodenal Switch Procedure "Duodenal-Jejunal Bypass" (Diabetes Surgery) As A Potential Cure for Type 2 Diabetes Mellitus in Non-Obese Patients- a Pilot Project to Validate a Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT00562029
- Acronym / sponsor ID
- DJB / djb-2007
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Surgery, Duodenal Bypass, Resolution, Surgical Procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sound Shore Medical Center of WestchesterUniversity, hospital or other
- Collaborators
- Maffucci L, Rangraj M
- Study start
- Nov 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Nov 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.
Premise: Complete resolution of Type 2 Diabetes Mellitus with normalization of blood glucose and HbA1c in the abscence of medication support is possible with a surgical procedure named the "Duodenal-Jejunal Bypass (DJB)" a modification of an established duodenal switch procedure and is performed utilizing the laparoscopic approach.
Detailed description
Hypothesis: The duodenum plays a major role in glucose homeostasis through mechanisms largely unknown at this time. Evidence of this hypothesis comes from accumulated data in bariatric surgery patients who underwent Roux-en-y Gastric Bypass or Biliopancreatic Diversion (BPD) with or without a Duodenal Switch. Current evidence strongly supports this hypothesis with a long term (over 10 years) Type 2 Diabetes Mellitus(T2DM) resolution rate of 84-86% following the gastric bypass and over 95% for the duodenal switch.
The clinical resolution of T2DM is defined as independence of all anti-diabetic medications and maintaining a HbA1c less than 6.0. Recent rodent experiments by Francesco Rubino and subsequent human case reports by Cohen et al. supports the validity of this hypothesis. The modified procedure involved a roux-en-y bypass of the duodenum and 30-50cm of proximal jejunum, unaltering the stomach and pylorus resulted in resolution of T2DM with no weight loss in all subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DJB patient | Experimental | Procedure: Duodenal-jejunal BypassPatient has undergone a duodeno-jejunal bypass |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Established diagnosis of Type 2 diabetes mellitus
- Body Mass Index(BMI) less than 35
- Insulin usage duration less than 10 years
- Negative anti-GAD
- Fasting C-peptide level over 1.0 mcg/ml
Key exclusion criteria (15 listed)
- Current pregnancy or positive pregnancy test
- Liver Cirrhosis
- Coagulopathy
- Type 1 Diabetes Mellitus
- HIV
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 BypassPatient has undergone a duodenal bypass and bypass of 60cm of proximal jejunum | Procedure or surgery | DJB patient |
Primary outcome
Measure: Resolution of Type 2 Diabetes Mellitus
Time frame: One year
1 secondary outcome
Measure: Safety and efficacy of duodenal-jejunal bypass
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 21 May 2015.
- Background: PubMed 17060767Rubino F, Forgione A, Cummings DE, Vix M, Gnuli D, Mingrone G, Castagneto M, Marescaux J. The mechanism of diabetes control after gastrointestinal bypass surgery reveals a role of the proximal small intestine in the pathophysiology of type 2 diabetes. Ann Surg. 2006 Nov;244(5):741-9. doi: 10.1097/01.sla.0000224726.61448.1b.
- Background: PubMed 15479938Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.
- Results publication: PubMed 17386391Cummings DE, Overduin J, Foster-Schubert KE, Carlson MJ. Role of the bypassed proximal intestine in the anti-diabetic effects of bariatric surgery. Surg Obes Relat Dis. 2007 Mar-Apr;3(2):109-15. doi: 10.1016/j.soard.2007.02.003. No abstract available.
- Results publication: PubMed 17386401Cohen RV, Schiavon CA, Pinheiro JS, Correa JL, Rubino F. Duodenal-jejunal bypass for the treatment of type 2 diabetes in patients with body mass index of 22-34 kg/m2: a report of 2 cases. Surg Obes Relat Dis. 2007 Mar-Apr;3(2):195-7. doi: 10.1016/j.soard.2007.01.009. No abstract available.
- click here for information on background to present studyLink provided by the sponsor.
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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.
Leonard Maffucci, MD principal investigator
Sound Shore Medical Center of Westchester
Madhu S Rangraj, MD principal investigator
Sound Shore Medical Center of Westchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duodenal-jejunal Bypass in people with Type 2 Diabetes Mellitus, run by Sound Shore Medical Center of Westchester 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 8 inclusion and 15 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 May 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 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?
Measure: Resolution of Type 2 Diabetes Mellitus (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00562029, which also lists 4 linked publications.
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 May 2015.