Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus, Surgery, Duodenal Bypass, Resolution, Surgical Procedures
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.
Interventions
PROCEDUREDuodenal-jejunal Bypass
Patient has undergone a duodenal bypass and bypass of 60cm of proximal jejunum
Sponsors
Maffucci L, Rangraj M
Sound Shore Medical Center of Westchester
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measure: Resolution of Type 2 Diabetes Mellitus | One year |
Secondary
| Measure | Time frame |
|---|---|
| Measure: Safety and efficacy of duodenal-jejunal bypass | One year |
Countries
United States
Outcome results
None listed