Clinical trial NCT01529216: Efficacy Study of the DIAMOND System to Treat Type 2 Diabetes Mellitus
Official title: An Advanced Configuration (The Third Generation) of the DIAMOND System for the Treatment of T2DM Patients - A Randomized, Double Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: DIAMOND System
T2DM
Randomized study
Electrical stimulation
Fundus
Lead sponsor: MetaCure Limited
Sponsor class: INDUSTRY
First posted: 2012-02-08
Enrollment: 2
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study purpose is to demonstrate the benefit of a simplified version of the DIAMOND System (A third Generation) in comparison to a sham treatment in terms of Glycemic control, measured as A1c, FBG and Post-Prandial Glucose levels.

The study hypothesis is that HbA1c will show greater improvement in patients receiving 12 months of therapy by the DIAMOMD System than in patients not receiving this therapy.

Detailed description: The study protocol will also apply measures to better understand the mechanism of action of the effect.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects 21 through 70 years of age
* Body mass index ≥28 and ≤ 45 (kg/m2)
* Type 2 diabetes duration more than 6 months and less than 10 years.
* A baseline measurement (visit BL1) of HbA1c between ≥ 7.5% and ≤ 10.5%,
* Type 2 diabetic subjects treated for at least 3 months with one or more maximum tolerable dosage of anti-diabetic agent (Any of the following: Sulfonylurea, Metformin, thiazolinedione (TZD), DPP-4 inhibitors).
* Stable anti-hypertensive and lipid-lowering medication for at least one month prior to enrollment, if taken
* Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods
* Ability and willingness to perform required study and data collection procedures and adhere to operating requirements of the System
* Alert, mentally competent, and able to understand and willing to comply with the requirements of the clinical trial, and personally motivated to abide by the requirements and restrictions of the clinical trial
* Able to provide voluntary informed consent

Exclusion Criteria:

* Injectable anti-diabetic therapy within the last 3 months (such as insulin and/or GLP-1 receptor agonists)
* Taking medications known to affect gastric motility such as narcotics (chronic use) and anticholinergics/antispasmodics
* Any gastric or upper GI surgery
* Experiencing severe and progressing diabetic complications (i.e. retinopathy not stabilized, nephropathy with macroalbuminuria)
* Prior wound healing problems
* Diagnosed with past or current psychiatric condition that may impair his or her ability to comply with the study procedures
* Use of anti-psychotic medications
* Diagnosed with an eating disorder such as bulimia or binge eating
* Obesity due to an endocrinopathy (e.g. Cushing disease, Hypothyroidism not treated)
* Hiatal hernia requiring surgical repair or a paraesophageal hernia
* Pregnant or lactating
* Diagnosed with impaired liver function (liver enzymes 3 times greater than normal)
* Any prior bariatric surgery
* Any history of pancreatitis
* Any history of peptic ulcer disease within 10 years of enrollment
* Diagnosed with Gastroparesis or other GI motility disorder
* Use of active medical devices (either implantable or external) such as ICD, pacemaker, drug infusion device, or neurostimulator (either implanted or worn). Subjects using an external active device who are able and willing to avoid use of the device during the study may be enrolled.
* Cardiac history that physician /surgeon feels should exclude the subject from the study.
* Use of another investigational device or agent in the 30 days prior to enrollment
* A history of life-threatening disease within 5 years of enrollment
* Any additional condition(s) that in the Investigator"s opinion would warrant exclusion from the study or prevent the subject from completing the study

Primary outcomes:
measure: HbA1c
timeFrame: 12 months
Secondary outcomes:
measure: HbA1c
timeFrame: 6 months
measure: GI hormones (C-peptide, Glucagon, Ghrelin, GLP-1, PYY, Gastrin and Somatostatin)
timeFrame: 6 and 12 months
measure: Metabolic parameters (fasting and post Prandial glucose, blood pressure, lipids and cholesterol, weight and waist circumference)
timeFrame: 6 and 12 months
measure: Triglycerides
timeFrame: Baseline
measure: HbA1c
timeFrame: 24 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hospital Georges Pompidou
city: Heerlen
country: Netherlands
facility: Atrium Medisch Centrum
Study officials:
affiliation: Atrium medisch centrum METC, Heerlen, The Netherlands
name: Jan W.M. Greve, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital GEORGES POMPIDOU 20 Rue Leblanc 75015 Paris, France
name: Chevallier, MD
role: PRINCIPAL_INVESTIGATOR
References: