CLINICAL TRIAL

iRF System Hepatic Denervation for Diabetes Mellitus, Type 2

Waitlist Available · 18+ · All Sexes · Coon Rapids, MN

This study is evaluating whether a new type of surgery may help improve blood sugar levels in patients with type 2 diabetes.

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About the trial for Diabetes Mellitus, Type 2

Treatment Groups

This trial involves 2 different treatments. IRF System Hepatic Denervation 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
iRF System Hepatic Denervation
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
An individual who is ≥22 years old and ≤70 years old. show original
This text is saying that if a person's waist circumference is over 102 cm for a male or over 88 cm for a female then they are considered obese. show original
for the prevention of CVD There is evidence that stable lifestyle modifications can help prevent cardiovascular disease show original
and for at least 4 weeks before the first dose of study medication WOCBP must use contraception for the entire study and for 4 weeks before the first dose of study medication. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 30, 90, 180 and 365 days
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 30, 90, 180 and 365 days.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether iRF System Hepatic Denervation will improve 1 primary outcome and 7 secondary outcomes in patients with Diabetes Mellitus, Type 2. Measurement will happen over the course of Index Procedure through 90 days.

Rate of Serious Adverse Device Effects
INDEX PROCEDURE THROUGH 90 DAYS
The incidence rate of serious adverse device effects (SADEs) from time of Index Procedure through 90 days.
Adverse Event rate 365 days
CONSENT THROUGH 365 DAYS
Adverse Event rate: Summary of all reported adverse events during the study
Change in liver steatosis
90 AND 365 DAYS
Change from baseline in liver steatosis from baseline as measured using MRI-PDFF
Change in office blood pressure
30, 90, 180 AND 365 DAYS
Change from baseline in office blood pressure: systolic and diastolic
Change in glycemic control - C-peptide
30, 90, 180 AND 365 DAYS
Change from baseline in glycemic control as indicated by c-peptide blood test during Mixed Meal Tolerance Test
Change in glycemic control - Insulin
30, 90, 180 AND 365 DAYS
Change from baseline in glycemic control as indicated by insulin blood test during Mixed Meal Tolerance Test
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for diabetes mellitus, type 2?

We recommend a multidisciplinary management approach to diabetes, including medication, education and diet. Appropriate medications for the management of diabetes are the most common and significant aspect of medication management.

Anonymous Patient Answer

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

Results from a recent clinical trial reveals a substantial burden of diabetes mellitus, type 2 on the US health care system and its economic burden. The need to decrease the high incidence of diabetes mellitus, type 2 identifies important public health needs to be addressed to reduce the future burden on the U.S. healthcare system.

Anonymous Patient Answer

Can diabetes mellitus, type 2 be cured?

The overall health-promoting potential of diabetes treatment is uncertain. Even in cases of severe insulin resistance and complications, treatment with anti-diabetic drugs often cannot prevent progression towards diabetic complications. However, even if diabetic complications cannot be stopped, some treatment options can prevent future complications. It is unclear whether this applies to people without hyperglycemia.

Anonymous Patient Answer

What are the signs of diabetes mellitus, type 2?

There are several signs and symptoms suggestive of diabetes mellitus, type 2 (DM, DM2). This article covers in order of frequency, symptoms that are the most prominent.

Anonymous Patient Answer

What causes diabetes mellitus, type 2?

Although diabetes is a disease of unprecedented proportions in both adults and adolescents, the underlying causes are varied. This highlights the need for personalized medicine approaches to the treatment of diabetes and other complex chronic diseases.

Anonymous Patient Answer

What is diabetes mellitus, type 2?

Patients with [type 2 diabetes](https://www.withpower.com/clinical-trials/type-2-diabetes) are at significant risk for developing retinopathy with some risk factors including pre-morbid nephropathy in those being treated with anti-diabetic medications (S,P-glycoprotein), elevated HbA1c, family history of diabetes and duration of diabetes. It is essential for clinicians to anticipate and treat any diabetic eye disease in patients being treated with anti-diabetic medication, and to consider the importance of tight glucose control in patients with diabetes.

Anonymous Patient Answer

What are the common side effects of irf system hepatic denervation?

The present study indicates the possible side effects of hepatic denervation induced by the rinsing of the irf system, which were not previously reported. Most of the reported side effects of irf system denervation are the same as those of surgical denervation. Findings from a recent study provide valuable information for potential future clinical application of irf system denervation.

Anonymous Patient Answer

Does irf system hepatic denervation improve quality of life for those with diabetes mellitus, type 2?

The IRF system hepatic denervation using BPN and the treatment of diabetes mellitus, type 2 by oral hypoglycemic agents resulted in a better functional and a significant improvement in quality of life.

Anonymous Patient Answer

What is irf system hepatic denervation?

The current study demonstrated that ischemia/reperfusion and obesity resulted in the reduced expression of insulin receptors (IR-1) and reduced fasting glucose and glucose responsiveness on fasting test, while glucagon action was preserved through an IRE-dependent reduction in IR. However, denervation of IIR did not alter its activity of hepatic insulin clearance during the clamp test of hyperglycemia. Therefore, IR system liver denervation does not alter glucose tolerance in type 2 diabetes.

Anonymous Patient Answer

What are the latest developments in irf system hepatic denervation for therapeutic use?

In the present study, we presented our own experience with the application of irf system hepatic denervation for the treatment of diabetic fatty liver disease.

Anonymous Patient Answer

How does irf system hepatic denervation work?

The insulin-induced suppression of circulating glucose levels in denervated animals implies the presence of a hepatic insulin-dependent feedback loop. It has been proposed that this feedback loop is regulated by a neural system in the liver, but in this study no evidence of neuronal degeneration or denervation was observed at this postmortem time.

Anonymous Patient Answer

Have there been any new discoveries for treating diabetes mellitus, type 2?

The current treatments for patients with [type 2 diabetes](https://www.withpower.com/clinical-trials/type-2-diabetes) mellitus are adequate and effective, when properly delivered. However, recent advances in diabetes mellitus, type 2 treatment include some of the newer classes of drugs and devices, which may provide a significant benefit in the treatment of patients with type 2 diabetes mellitus.

Anonymous Patient Answer
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