Balance System Study in Type 2 Diabetic Patients

January 23, 2012 updated by: Beta-Stim Ltd.

Evaluation of the BALANCE System in Type 2 Diabetic Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany
        • University Clinic Hamburg-Eppendorf (UKE)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beta-Stim Ltd.

Collaborators

Meditrial Europe Ltd.

Investigators

  • Principal Investigator: Jakob R Izbicki, Prof. Dr. med, The University Medical Center Hamburg-Eppendorf (UKE), Department of General, Visceral- and Thoracic-Surgery, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

March 28, 2009

First Submitted That Met QC Criteria

March 30, 2009

First Posted (Estimate)

March 31, 2009

Study Record Updates

Last Update Posted (Estimate)

January 24, 2012

Last Update Submitted That Met QC Criteria

January 23, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 598500

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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