Balance System Study in Type 2 Diabetic Patients - Full Text View

Sponsors and Collaborators:	Beta-Stim Ltd. Meditrial Contract Research Organization www.meditrialeurope.com
Information provided by:	Beta-Stim Ltd.
ClinicalTrials.gov Identifier:	NCT00872846

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Obesity	Device: BALANCE System intestinal electrical stimulator	Phase I

MedlinePlus related topics: Diabetes Endocrine Diseases Metabolic Disorders Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Evaluation of the BALANCE System in Type 2 Diabetic Patients

Further study details as provided by Beta-Stim Ltd.:

Primary Outcome Measures:

Evaluation of the of device and/or procedure related adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Significant decrease in the HbA1c values from baseline [ Time Frame: at week 4, and at month 2,3,4,5,6,8,10,12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	February 2009
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872846

Locations

Germany
University Clinic Hamburg-Eppendorf (UKE)	Recruiting
Hamburg, Germany
Contact: Jakob R Izbicki, Prof. Dr. med +49-4717 ext 4403
Principal Investigator: Jakob R Izbicki, Prof. Dr. med

Sponsors and Collaborators

Beta-Stim Ltd.

Meditrial Contract Research Organization www.meditrialeurope.com

Investigators

Principal Investigator:

Jakob R Izbicki, Prof. Dr. med

The University Medical Center Hamburg-Eppendorf (UKE), Department of General, Visceral‐ and Thoracic‐Surgery, Germany

More Information

No publications provided

Responsible Party:	Beta-Stim Ltd ( Jacob BenArie, CEO )
Study ID Numbers:	598500
Study First Received:	March 28, 2009
Last Updated:	March 30, 2009
ClinicalTrials.gov Identifier:	NCT00872846 History of Changes
Health Authority:	Germany: Ethics Commission; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Beta-Stim Ltd.:

Body weight
Signs and symptoms
Obesity
Metabolic disease
Diabetes mellitus type 2
Diabetes mellitus

Nutrition disorder
Endocrine system diseases
Overweight
Overnutrition
Glucose metabolic disorder

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Overweight
Insulin
Body Weight

Signs and Symptoms
Diabetes Mellitus, Type 2
Nutrition Disorders
Overnutrition
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus

Nutrition Disorders
Endocrine System Diseases
Overweight
Overnutrition
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009