- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00562029
Study of Duodenal-Jejunal Bypass(DJB) as a Potential Cure for Type 2 Diabetes Mellitus (DJB)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New Rochelle, New York, United States, 10802
- Sound Shore Medical Center of Westchester
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Current pregnancy or positive pregnancy test
- Liver Cirrhosis
- Coagulopathy
- Type 1 Diabetes Mellitus
- HIV
- Previous abdominal surgery preventing laparoscopy
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DJB patient
Patient has undergone a duodeno-jejunal bypass
|
Patient has undergone a duodenal bypass and bypass of 60cm of proximal jejunum
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measure: Resolution of Type 2 Diabetes Mellitus
Time Frame: One year
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measure: Safety and efficacy of duodenal-jejunal bypass
Time Frame: One year
|
One year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Leonard Maffucci, MD, Sound Shore Medical Center of Westchester
- Principal Investigator: Madhu S Rangraj, MD, Sound Shore Medical Center of Westchester
Publications and helpful links
General Publications
- Buchwald 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. Erratum In: JAMA. 2005 Apr 13;293(14):1728.
- 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.
- Cummings 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.
- Cohen 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- djb-2007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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