Effect of E Balance Pro Therapy on Diabetes and Related Complications

NCT03172260 | Completed

• 1 other identifier: CELLRPD-160001-RPD00
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational study, to test the hypothesis that E Balance Pro Therapy micro-current treatments, delivered with precision in amplitude, waveform and pulsing pattern, adapted by other aspects of this device's technology could affect ion flow across cells and tissues in a fashion that modifies or transforms a crucial pathophysiologic deficit present in patients with diabetes. E Balance Pro Therapy can supplement standard treatment, as an adjunct, and help patients better manage their diabetes. HbA1C is the primary endpoint of this study. However, we expect to see changes in other symptoms (if present) associated with diabetes such as: blood pressure, insulin sensitivity, neuropathic pain retinopathy and wound healing.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• HbA1c

  change from baseline

  3 months

Secondary Outcomes (1)

• Kidney function

  3 months

Interventions

E Balance Pro Therapy DEVICE

Micro-current treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with a diagnosis of Type 1 or Type 2 Diabetes

You may qualify if:

• Male or female adults \> 18 years of age.
• HbA1c 7.0% to 11.0% (inclusive).
• Body mass index 40.0kg/m2 or less.
• Non-smoker, or ex-smoker ≥3 months.
• Female participants of childbearing potential \[i.e. not surgically sterilized or post-menopausal (greater than one year since last menses)\] must have negative urine pregnancy test and must be using an effective birth control method, defined as:
• Continuous use of oral or long acting injected contraceptive for at least 2 months prior to study entry, or
• Use of an intra-uterine device or implantable contraceptive, or
• Use of double barrier methods of birth control, or
• Abstinence from heterosexual intercourse.
• Currently on lifestyle management and/or standard treatment for diabetes.
• Currently under the care of a physician.
• Able and willing to perform self-monitoring of plasma glucose regularly.
• Willing to avoid alcohol consumption for 24 h prior to every clinic visit.
• Willing to maintain a stable body weight, activity level, and dietary pattern, except for use of the study products, as directed.
• Willing and able to provide informed written consent prior to any study procedures.

You may not qualify if:

• Pregnancy or lactation, or participant unwilling to take appropriate contraceptives for the duration of the study
• History of significant cardiovascular or coronary heart disease (CVD or CHD) as defined by having had a coronary artery bypass procedure, coronary stent or angioplasty, or myocardial infarction in the past six (6) months.
• Current or recent (within six month of Visit 1) history of significant gastrointestinal, renal, pulmonary, hepatic or biliary disease, other endocrine diseases or invasive weight loss treatment.
• Subjects currently using pacemakers.
• History of epilepsy.
• Uncontrolled hypertension (blood pressure SBP \> 180 and/or DBP ≥ 105 mm Hg) and unstable use (i.e. initiation or change in dose) of antihypertensive medications or thyroid hormone replacement medications within 3 months prior to Visit 1.
• Plasma creatinine above 130µmol/L or ALT more than twice (2x) upper limit of normal.
• Use of anticoagulants such as (not exhaustive):warfarin (Coumadin), dabigatran (Pradaxa), apixaban (Eliquis) or rivaroxaban (Xarelto). NOTE: Anti-platelet agents such as Plavix are allowed.
• Use of prescription non-steroidal anti-inflammatory drugs (or daily use of over the counter non-steroidal anti-inflammatory drugs \>1month), steroids, corticosteroids, or any other prescription anti-inflammatory drugs within three (3) months prior to Visit 1.
• Use of any weight-loss programs or weight-loss medications (prescription or over- the counter) including, but not limited to, lipase inhibitors, within three (3) months prior to Visit 1.
• History of cancer (excluding non-melanoma skin cancer and basal cell carcinoma) in the past five (5) years.
• Presence or history (past 6 months) of alcohol or drug abuse; alcohol use of \>2 standard alcoholic drinks per day (one drink= 12oz. beer, 4 oz. wine, 1.5 oz. hard liquor).
• Subject planning to undergo surgery during the study period or up to one (1) month after the study.
• Participant has a known allergy or intolerance to the test products or placebo.
• Participant is unwilling or unable to abide by the requirements of the protocol.

Sponsors & Collaborators

• CellMedX Corporation: lead
• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator

Study Sites (1)

Hamilton Medical Research Group

Hamilton, Ontario, L8M 1K7, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: June 1, 2017
• Study Start: February 8, 2017
• Primary Completion: July 20, 2017
• Study Completion: July 20, 2017
• Last Updated: January 31, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)