Balance System Study in Type 2 Diabetic Patients

This study has been completed.
Sponsor:
Collaborator:
Meditrial SrL
Information provided by (Responsible Party):
Beta-Stim Ltd.
ClinicalTrials.gov Identifier:
NCT00872846
First received: March 28, 2009
Last updated: January 23, 2012
Last verified: January 2012
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the BALANCE System in Type 2 Diabetic Patients

Resource links provided by NLM:


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 ]

Enrollment: 20
Study Start Date: February 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Name: BALANCE System
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
University Clinic Hamburg-Eppendorf (UKE)
Hamburg, Germany
Sponsors and Collaborators
Beta-Stim Ltd.
Meditrial SrL
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

Additional Information:
No publications provided

Responsible Party: Beta-Stim Ltd.
ClinicalTrials.gov Identifier: NCT00872846     History of Changes
Other Study ID Numbers: 598500
Study First Received: March 28, 2009
Last Updated: January 23, 2012
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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Obesity
Body Weight
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014