The Endogenex Device for Endocrine System Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mayo Clinic, Rochester, MN
Endocrine System Diseases+6 More
The Endogenex Device - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a device can help people with diabetes.

See full description

Eligible Conditions

  • Endocrine System Diseases
  • Diabetes Mellitus
  • Metabolic Diseases
  • Diabetes
  • Glucose Metabolism Disorders
  • Diabetes Mellitus, Type 2
  • Diabetes Type 2

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether The Endogenex Device will improve 1 primary outcome, 9 secondary outcomes, and 2 other outcomes in patients with Endocrine System Diseases. Measurement will happen over the course of 12 weeks post-procedure.

12 weeks post-procedure
Primary Safety Endpoint
Week 48
Changes in HbA1c
Changes in Weight
Changes in alanine aminotransferase (ALT)
Changes in aspartate aminotransferase (AST)
Changes in fasting plasma glucose
Changes in glucose-lowering medication usage
Changes in insulin resistance
Changes in post-prandial glucose
Changes systolic and diastolic blood pressure
At the time of procedure
Procedural Time
Procedural success

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Interventional
1 of 1
Experimental Treatment

This trial requires 20 total participants across 1 different treatment group

This trial involves a single treatment. The Endogenex Device is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Interventional
Device
All eligible patients will receive the endoscopic Endogenex procedure.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at the time of procedure
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at the time of procedure for reporting.

Closest Location

Mayo Clinic - Rochester, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
22- 65 years of age
Current diagnosis of T2D
History of T2D for at least 3 years and less than or equal to 10 years
HbA1C of 7.5-10.0%, inclusive
BMI 24-40 kg/m2, inclusive
On two to three non-insulin glucose lowering mediations, with one at maximum tolerated dose and another at half-maximum dose at least, with no changes in medication for at least 12 weeks prior to baseline visit prior to baseline visit
History of failed attempt to reach glycemic goal by lifestyle modifications
Weight stability (defined as a < 5% change in body weight) for at least 12 weeks prior to the screening visit
Agree not to donate blood during participation in the study.
Able to comply with study requirements and understand and sign the Informed Consent Form

Patient Q&A Section

What are the signs of diabetes type 2?

"Symptoms that may indicate diabetes type 2 include numbness and tingling in the feet which are unrelated to peripheral neuropathy, and it is important to remember that even in the absence of these symptoms, the diagnosis of diabetic neuropathy is justified." - Anonymous Online Contributor

Unverified Answer

What causes diabetes type 2?

"Diabetes type 2 is a genetically determined disorder affecting about 5% of the population and increasing with frequency. It is a serious condition that impairs daily life and can be avoided. People with diabetes should take an active role in controlling their condition." - Anonymous Online Contributor

Unverified Answer

Can diabetes type 2 be cured?

"Patients with diabetes type 2 who continue their dietary regimen that keeps A1C > 7.0 % will see a significant decrease in beta-cell production. Over time, beta cells will become more productive. Those who do not respond to high-dose treatment will not improve at this rate." - Anonymous Online Contributor

Unverified Answer

What are common treatments for diabetes type 2?

"Some of the treatments for [type 2 diabetes](https://www.withpower.com/clinical-trials/type-2-diabetes), such as weight loss therapy or hypoglycemic medicines, are commonly used by patients with type 2 diabetes, but not by those with type 1 diabetes. The other treatments, such as insulin pump therapy, were commonly used by both type 1 and type 2 patients with diabetes.\n" - Anonymous Online Contributor

Unverified Answer

What is diabetes type 2?

"The first clinical manifestation of [diabetes type 2](https://www.withpower.com/clinical-trials/diabetes-type-2) is impaired fasting glucose (IFG). Later abnormalities are manifest in diabetes as impaired glucose tolerance (IGT) or type 2 diabetes (T2DM)." - Anonymous Online Contributor

Unverified Answer

How many people get diabetes type 2 a year in the United States?

"Diabetes type 2 is highly prevalent and will become more so. The incidence of [diabetes type 2](https://www.withpower.com/clinical-trials/diabetes-type-2) will be even higher if treatment rates remain low. Diabetes mellitus had been considered as a high-risk disease in previous reports, however, recent studies have suggested that it should be considered to be a low-risk disease too." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of the endogenex device?

"The endogenex device is well tolerated and effective in controlling blood glucose levels in patients with both T2DM and IGT/impaired glucose tolerance. The side effects reported include nausea, abdominal discomfort, sore mouth and throat, fatigue, and upper gastrointestinal distress. In conclusion, the endogenex device is a safe, reliable treatment modality for patients with T2DM and IGT/impaired glucose tolerance." - Anonymous Online Contributor

Unverified Answer

Has the endogenex device proven to be more effective than a placebo?

"Results from a recent clinical trial does not support the claim that the EMD-100 has an effect on insulin response to the OGTT. It may be possible to better define the endogenex device's place in the treatment of individuals with type 2 diabetes." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of diabetes type 2?

"Results from a recent paper highlight the role of genetic susceptibility, which is clearly present in the first 20 years of life, as the most significant risk factor for diabetes type 2. Results from a recent paper also emphasize the importance of implementing genetic screening programmes for children at the family level." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for diabetes type 2?

"It is hard to convince the patients that they benefit from being included in an RCT, and the investigators’ perceptions that type 2 diabetes patients do not respond well to randomised clinical trials is not supported by the findings of studies which have been conducted thus far in type 2 diabetes. Patients must also be informed of the possibility of severe adverse events that are associated with an RCT." - Anonymous Online Contributor

Unverified Answer

Does the endogenex device improve quality of life for those with diabetes type 2?

"EndocrineEX device could be a useful tool to improve QOL in people with type 2 diabetes because of its positive effects on treatment adherence, weight loss, and self-care." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving the endogenex device?

"There are a handful of other devices with claims to be able to reverse type 2 diabetes. However, none have been subjected to clinical trials to document their safety and efficacy, and none employ the clinical research-grade technology of endogenex. Endogenex is a well-established device used by a single company in a variety of clinical trials that are completed only in the United States under an FDA review process. These trials are carefully monitored and monitored, with the manufacturer providing documentation that any data collected are used only from human subjects in the research without compensation or product sales and that the device has been validated." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Endocrine System Diseases by sharing your contact details with the study coordinator.