Balance System Study in Type 2 Diabetic Patients

Beta-Stim

Status and phase

Completed

Phase 1

Conditions

Obesity

Type 2 Diabetes

Treatments

Device: BALANCE System intestinal electrical stimulator

Study type

Interventional

Funder types

Industry

Identifiers

NCT00872846

598500

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

20 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.