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- Klinische proef NCT00872846
Balance System Study in Type 2 Diabetic Patients
Evaluation of the BALANCE System in Type 2 Diabetic Patients
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Hamburg, Duitsland
- University Clinic Hamburg-Eppendorf (UKE)
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Evaluation of the of device and/or procedure related adverse events
Tijdsspanne: 12 months
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12 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Significant decrease in the HbA1c values from baseline
Tijdsspanne: at week 4, and at month 2,3,4,5,6,8,10,12
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at week 4, and at month 2,3,4,5,6,8,10,12
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Jakob R Izbicki, Prof. Dr. med, The University Medical Center Hamburg-Eppendorf (UKE), Department of General, Visceral- and Thoracic-Surgery, Germany
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 598500
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op BALANCE System intestinal electrical stimulator
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Mayo ClinicVoltooidEvenwichtsstoornisVerenigde Staten