Study of Duodenal-Jejunal Bypass(DJB) as a Potential Cure for Type 2 Diabetes Mellitus

NCT ID: NCT00562029

Last Updated: 2015-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2011-12-31

Brief 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 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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DJB patient

Patient has undergone a duodeno-jejunal bypass

Group Type: EXPERIMENTAL

Duodenal-jejunal Bypass

Intervention Type: PROCEDURE

Patient has undergone a duodenal bypass and bypass of 60cm of proximal jejunum

Interventions

Duodenal-jejunal Bypass

Patient has undergone a duodenal bypass and bypass of 60cm of proximal jejunum

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maffucci L, Rangraj M

UNKNOWN

Sponsor Role: collaborator

Sound Shore Medical Center of Westchester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leonard Maffucci, MD

Role: PRINCIPAL_INVESTIGATOR

Sound Shore Medical Center of Westchester

Madhu S Rangraj, MD

Role: PRINCIPAL_INVESTIGATOR

Sound Shore Medical Center of Westchester

Locations

Sound Shore Medical Center of Westchester

New Rochelle, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 17060767 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15479938 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17386391 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17386401 (View on PubMed)

Related Links

http://ees.elsevier.com/soard/

click here for information on background to present study

Other Identifiers

djb-2007

Identifier Type: -

Identifier Source: org_study_id