Balance System Study in Type 2 Diabetic Patients

Study Overview
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Brief Summary
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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 clinical and metabolic parameters will be studied.

Detailed Description
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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 smaller amounts of food than normal. In addition, duodenal stimulation has been shown to induce favorable changes in postprandial glucose levels, glucose tolerance testing and insulin levels. The target population type II diabetic patients uncontrolled with oral medications, and with overweight (BMI >30). The Balance System may overcome the known disadvantages of insulin therapy and allow early treatment of these patients, potentially preventing the progression of obesity and diabetes.

Official Title
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Evaluation of the BALANCE System in Type 2 Diabetic Patients

Conditions
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Type 2 Diabetes, Obesity

Intervention / Treatment
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* Device: BALANCE System intestinal electrical stimulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: BALANCE System intestinal electrical stimulator|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 smaller amounts of food than normal. In addition, duodenal stimulation has been shown to induce favorable changes in postprandial glucose levels, glucose tolerance testing and insulin levels.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the of device and/or procedure related adverse events |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant decrease in the HbA1c values from baseline |  | at week 4, and at month 2,3,4,5,6,8,10,12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Body weight, Signs and symptoms, Obesity, Metabolic disease, Diabetes mellitus type 2, Diabetes mellitus, Nutrition disorder, Endocrine system diseases, Overweight, Overnutrition, Glucose metabolic disorder