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

NCT00562029 | Completed DMC

• 1 other identifier: djb-2007
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes Mellitus; Surgery; Duodenal Bypass; Resolution; Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• Measure: Resolution of Type 2 Diabetes Mellitus

  One year

Secondary Outcomes (1)

• Measure: Safety and efficacy of duodenal-jejunal bypass

  One year

Study Arms (1)

DJB patient

EXPERIMENTAL

Patient has undergone a duodeno-jejunal bypass

Procedure: Duodenal-jejunal Bypass

Interventions

Duodenal-jejunal Bypass PROCEDURE

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

DJB patient

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sound Shore Medical Center of Westchester: lead
• Maffucci L, Rangraj M: collaborator

Study Sites (1)

Sound Shore Medical Center of Westchester

New Rochelle, New York, 10802, United States

Location

Related Publications (4)

• 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.

  PMID: 17060767 BACKGROUND

• 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.

  PMID: 15479938 BACKGROUND

• 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.

  PMID: 17386391 RESULT

• 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.

  PMID: 17386401 RESULT

Related Links

• click here for information on background to present study

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Leonard Maffucci, MD

  Sound Shore Medical Center of Westchester

  PRINCIPAL INVESTIGATOR

• Madhu S Rangraj, MD

  Sound Shore Medical Center of Westchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2007
• First Posted: November 21, 2007
• Study Start: November 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 21, 2015

Record last verified: 2015-05

Locations

US (1)