Status:
COMPLETED
Neuroendocrine Brake for Type 2 Diabetes Mellitus
Lead Sponsor:
Medtronic - MITG
Conditions:
Diabetes
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Evaluation to determine the safety of two laparoscopic procedures to control T2DM.
Eligibility Criteria
Inclusion
- \- Male and female between 18 and 65 years.
- BMI 25.1 - 34.9.
- Type 2 diabetic patients on oral anti-diabetic agents and/or insulin treatment for a minimum of 12 months prior the enrollment.
- Diagnosis of T2DM for at least 3 years.
- Patient has been under routine care of hte study physician or another physician that can supply a reliable medical record for at least 3 years.
- HbA1c \>/ 7.5 documented for at least 3 months.
- Stable weight (nor significant weight change (\>3%) over the 3 months prior to enrollment.
- Stable medication for at least one month prior to enrollment except for diabetes medications which should be stable for at least 3 months prior to enrollment.
- Ability and willingness to return for all scheduled visits and participate in recommended parameter setting and physician recommended medical/laboratory assessments.
Exclusion
- Prior abdominal surgery, except laparoscopic cholecystectomy.
- Taking appetite suppressant.
- Severe eating disorders.
- Severe pulmonary, renal or cardiac disease.
- Obese due to a clinically diagnosed endocrine disorder.
- Subjects with impaired liver function.
- History of peptic ulcer disease.
- History of malignant disease.
- Use of prescription, over the counter or herbal weight loss products.
- Pregnant or planning on pregnancy while enrolled in study.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
September 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00450710
Start Date
March 1 2006
End Date
September 1 2009
Last Update
August 22 2014
Active Locations (1)
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1
Hospital de Especialidades
Goiânia, Brazil