Surgical Treatment of Type 2 Diabetes in Non-Morbidly Obese Patients

NCT00596973 | Withdrawn Phase 4 DMC

• 1 other identifier: AS07007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the short term success and feasibility of ileal transposition with sleeve gastrectomy in non-morbidly obese patients with poorly controlled Type 2 Diabetes Mellitus

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Treatment sucess based on patients' glycemic control

  12 Months

Study Arms (1)

Ileal transposition with SG

EXPERIMENTAL

Procedure: Surgical Treatment

Procedure: Surgical Treatment

Interventions

Surgical Treatment PROCEDURE

Ileal transposition with sleeve gastrectomy

Ileal transposition with SG

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed Type 2 Diabetes for 3 to 5 years.
• Poorly controlled blood sugar despite standard of care\* as demonstrated by HbA1c 8-11 for at least 6 months and 3 office visits. Standard of care is based on the ADA (American Diabetes Association) guidelines which include nutrition, exercise, education, behavior modification and pharmacological treatment. A co-investigator endocrinologist will ensure that the above standard of care has been met.
• BMI between 25.0 and 34.4.
• Stable weight as determined by no more than a 3% change in body weight in the last 3 months.
• Age between 35 and 65 (both men and women will be included).
• Able to provide Informed Consent.
• Able to comply with follow-up procedures.

You may not qualify if:

• Previous history of major abdominal surgery which may lead to a hostile abdomen.
• Pregnancy
• Patients who have an incurable malignant or debilitating disease
• Serious uncorrectable impairment of coagulation (INR\>1.4, PTT \> + 3 secs), lungs, kidney or heart
• Diagnosed severe eating disorder
• Use of medication for weight loss in the last 6 months
• Untreated endocrine disorder
• Active peptic ulcer
• Untreated H. pylori
• Cognitive Impairment
• Diabetic autonomic neuropathy
• Symptomatic gastroparesis

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Officials

• Barry Salky, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2007
• First Posted: January 17, 2008
• Study Start: January 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: March 1, 2009
• Last Updated: November 17, 2014

Record last verified: 2014-11

Locations

US (1)