Study of Duodenal-Jejunal Bypass(DJB) as a Potential Cure for Type 2 Diabetes Mellitus
Completed · Not applicable
Conditions studied: Type 2 Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT00562029
- Run by
- Sound Shore Medical Center of Westchester
- People needed
- 10
- Starts
- 2007-11-01
- Expected to finish
- 2011-12-01
- Last updated by the study team
- 2015-05-21
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Sound Shore Medical Center of Westchester — New Rochelle, New York, United States
Full record on ClinicalTrials.gov
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