Status:
COMPLETED
Balance System Study in Type 2 Diabetic Patients
Lead Sponsor:
Beta-Stim Ltd.
Collaborating Sponsors:
Meditrial Europe Ltd.
Conditions:
Type 2 Diabetes
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
To evaluate the safety and performance of the BALANCE System in treating patients who have type 2 diabetes and are overweight. Impact on blood glucose levels, weight loss, blood pressure and other cli...
Detailed Description
The BALANCE System stimulates the duodenum in a specialized way to strengthen the natural contractions and mimic the sensation of fullness (satiety). The patient is expected to feel full after eating ...
Eligibility Criteria
Inclusion
- Type 2 Diabetes inadequately controlled on a maximum of three oral anti-diabetic agents
- HbA1c between 7 and 10% inclusive
- Fasting Blood Glucose between 126 and 200 mg/dL
- Body Mass Index (BMI) in the range of 30.0 to 45.0 kg/m2
- Stable oral anti-diabetic therapy for at least 3 months
- Subjects who are able and willing to perform self monitoring of plasma glucose for the entire trial period
- Able and willing to sign informed consent and return for follow-up assessments
Exclusion
- Type 1 Diabetes
- Subjects at high risk of general anesthesia or surgery
- Subjects with prior pancreatitis
- Subjects treated with insulin within three months of screening
- Female with a positive pregnancy test, planning to become pregnant during screening, active treatment, or the follow up period, breastfeeding, or judged to be using inadequate contraceptive methods.
- Subjects who underwent previous intra abdominal, GI tract surgery or a major abdominal trauma.
- Subjects with other implanted electrical stimulation devices
- Subjects with motility disorders of the GI tract such as gastroparesis
- Subjects who are receiving medications known to affect gastric motility
- Subjects with history of peptic ulcer disease
- Subjects with any serious health condition, such as cancer, cardiac diseases, immunodeficiency disorders, liver disease, pulmonary disease, renal insufficiency, coagulopathy or a major depressive disorder.
- Subjects with severe diabetic complications, such as retinopathy or nephropathy
- Subjects with metabolic or endocrine disorders like primary or secondary Cushing syndrome
- Subjects who received another investigational agent within 30 days prior to screening
- Evidence of current or recent alcohol or drug abuse within the past year prior to screening
- Subjects who are unlikely to be available for follow-up as specified in the protocol
- Subjects with a past or present psychiatric condition that may impair his or her ability to comply with the study procedures
- Subjects with history of volvulus
- Subjects with history of known small bowel adhesions or any known GI adhesions
- Subjects with deficiencies of known vitamins, e.g. B12
- Subjects with known celiac disease or inflammatory bowel disease
- Subjects with conditions that, in the judgment of the investigator, precludes successful participation to the study.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00872846
Start Date
February 1 2009
End Date
January 1 2012
Last Update
January 24 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Clinic Hamburg-Eppendorf (UKE)
Hamburg, Germany