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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00596973 |
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Date of registration:
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28/11/2007 |
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Primary sponsor: |
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Public title:
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Surgical Treatment of Type 2 Diabetes in Non-Morbidly Obese Patients
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Scientific title:
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Phase IV Study of Surgical Treatment of Type 2 Diabetes in Non-Morbidly Obese Patients |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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10 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00596973 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Barry Salky, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mount Sinai School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Diagnosed Type 2 Diabetes for 3 to 5 years.
2. 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.
3. BMI between 25.0 and 34.4.
4. Stable weight as determined by no more than a 3% change in body weight in the last 3
months.
5. Age between 35 and 65 (both men and women will be included).
6. Able to provide Informed Consent.
7. Able to comply with follow-up procedures.
Exclusion Criteria:
1. Previous history of major abdominal surgery which may lead to a hostile abdomen.
2. Pregnancy
3. Patients who have an incurable malignant or debilitating disease
4. Serious uncorrectable impairment of coagulation (INR>1.4, PTT > + 3 secs), lungs,
kidney or heart
5. Diagnosed severe eating disorder
6. Use of medication for weight loss in the last 6 months
7. Untreated endocrine disorder
8. Active peptic ulcer
9. Untreated H. pylori
10. Cognitive Impairment
11. Diabetic autonomic neuropathy
12. Symptomatic gastroparesis
Age minimum:
35 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes
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Intervention(s)
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Procedure: Surgical Treatment
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Primary Outcome(s)
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Treatment sucess based on patients' glycemic control
[Time Frame: 12 Months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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