NCT00872846

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_1 type-2-diabetes

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_1 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 31, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 24, 2012

Status Verified

January 1, 2012

Enrollment Period

2.9 years

First QC Date

March 28, 2009

Last Update Submit

January 23, 2012

Conditions

Type 2 DiabetesObesity

Keywords

Body weightSigns and symptomsObesityMetabolic diseaseDiabetes mellitus type 2Diabetes mellitusNutrition disorderEndocrine system diseasesOverweightOvernutritionGlucose metabolic disorder

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the of device and/or procedure related adverse events

    12 months

Secondary Outcomes (1)

  • Significant decrease in the HbA1c values from baseline

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

Interventions

BALANCE System intestinal electrical stimulatorDEVICE

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.

Also known as: BALANCE System

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic Hamburg-Eppendorf (UKE)

Hamburg, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityBody WeightSigns and SymptomsMetabolic DiseasesDiabetes MellitusNutrition DisordersEndocrine System DiseasesOverweightOvernutritionGlucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesPathological Conditions, Signs and Symptoms

Study Officials

  • Jakob R Izbicki, Prof. Dr. med

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2009

First Posted

March 31, 2009

Study Start

February 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

January 24, 2012

Record last verified: 2012-01

Locations

DE(1)