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Type 2 DiabetesPhase 1NCT00872846

Balance System Study in Type 2 Diabetic Patients

A Phase 1 study testing BALANCE System intestinal electrical stimulator in people with Type 2 Diabetes and Obesity, run by Beta-Stim Ltd. at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 2 Diabetes, Obesity
What is being tested?
BALANCE System intestinal electrical stimulator
Type of treatment
Medical device
How many people
20 participants
Where
1 siteGermany
Study dates
Feb 2009to Jan 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 22Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Clinic Hamburg-Eppendorf (UKE)

    Hamburg

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
BALANCE System intestinal electrical stimulator
Keywords
Body weight, Signs and symptoms, Obesity, Metabolic disease, Diabetes mellitus type 2, Diabetes mellitus, Nutrition disorder, Endocrine system diseases, Overweight, Overnutrition, Glucose metabolic disorder
Medical subject headings
Diabetes Mellitus, Type 2, Obesity, Body Weight, Signs and Symptoms, Metabolic Diseases, Diabetes Mellitus, Nutrition Disorders, Endocrine System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BALANCE System intestinal electrical stimulatorDevice

    Also called BALANCE System

    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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of the of device and/or procedure related adverse events

    Measured: 12 months

Secondary outcomes (1)

  1. Significant decrease in the HbA1c values from baseline

    Measured: at week 4, and at month 2,3,4,5,6,8,10,12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionJan 2012
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00872846
Sponsor's protocol ID
598500
Status last verified
Jan 2012
First submitted
28 Mar 2009
Last updated
24 Jan 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BALANCE System intestinal electrical stimulator in people with Type 2 Diabetes and Obesity, run by Beta-Stim Ltd. at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the of device and/or procedure related adverse events (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00872846.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2012.

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