Is NCT06729996 recruiting in Rochester, MN?

Yes, NCT06729996 is currently recruiting participants at its Rochester, MN location. This chronic pancreatitis clinical trial is actively enrolling qualified participants.

How do I join the chronic pancreatitis clinical trial in Rochester?

To join this clinical trial in Rochester, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Rochester clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Chronic Pancreatitis Clinical Trial in Rochester, MN

About This Chronic Pancreatitis Study in Rochester

The purpose of this study is to evaluate efficacy of pioglitazone (PIO) versus empagliflozin (EMPA) to improve glycemic control in people with Chronic Pancreatitis (CP) or Recurrent Acute Pancreatitis (RAP) associated with Diabetes Mellitus (DM). To evaluate mixed meal response in PIO versus EMPA group to better understand physiology of both therapies in CP-DM.

Sponsor: Mayo Clinic

Who Can Participate

Inclusion Criteria

Age ≥18-80 years at the time of enrollment.

RAP or CP with DM diagnosed before or after CP diagnosis (Confirmed CP on imaging or RAP based on PROCEED study criteria, or acute pancreatitis followed by diabetes (AP-DM) and confirmed DM as per ADA criteria or clinically diagnosed with DM and on antihyperglycemic therapy)

Able to provide written informed consent and participate in longitudinal follow-up

A Stable retinal exam within 1 year prior to enrollment unless new onset diabetes was diagnosed within 6 months prior to study enrollment. If an eye exam within the past year is not available but the most recent exam is stable, a standard of care eye exam needs to be scheduled during the study period.

HbA1c level 6.5-10.5% at screening visit.

Current ongoing treatment with metformin and/or insulin and other antihyperglycemic medications will be accepted at screening. Patients will be willing to safely withdraw one or more study medication or mealtime insulin under the supervision of the study team by the time of screening. The patients clinical team will be informed promptly. Patients not on any antihyperglycemic medications are also eligible. a. If on a GLP-1 medication (e.g., semaglutide \[Ozempic, Wegovy, Rybelsus\], liraglutide, dulaglutide, exenatide, tirzepatide, etc.), the patient must be on a stable dose for at least 3 months prior to enrollment, with stable weight status at the time of enrollment and the GLP-1 dose cannot be escalated during the study period.

Willing to perform blood glucose and ketone testing on study provided meters as per study protocol.

Exclusion Criteria

Inability to take PIO or EMPA due to prior hypersensitivity or allergic reaction or current use of medications with potential for drug-drug interactions (Pioglitazone: Drug information - UpToDate, Empagliflozin: Drug information - UpToDate)

Patients on PIO or EMPA at the time of screening

Diagnosed with Type 1 Diabetes

Pregnancy or lactation in women (positive urine pregnancy test at screening will lead to exclusion)

History of bleeding disorders (e.g., Hemophilia A (factor VIII deficiency), hemophilia B (factor IX deficiency), von Willebrand disease, platelet disorders etc)

Presence of hepatic impairment, ALT \>3 x ULN with no etiology known at the time of enrollment or any evidence of acute/chronic liver disease

Ongoing treatment for any malignancy requiring systemic treatment (non-melanoma skin cancers treated in dermatologists' office would be acceptable)

Presence of osteoporosis without definitive treatment according to PI discretion.

Recent inflammatory illness within the 30 days preceding enrollment (e.g.: URTI, episode of AP, etc)

History of heart failure classified by NYHA as Class III or greater

History of kidney dysfunction classified by an eGFR of \<30 mL/min/min

Participation in any clinical trial within 30 days before screening for an approved or non-approved investigational medical product.

Active alcohol dependence or chemical dependence including tobacco based on investigator discretion

On a ketogenic diet

Autoimmune pancreatitis, obstructive pancreatitis, and prior surgery of pancreas (Whipple procedure, total pancreatectomy, and distal pancreatectomy)

Any condition which could jeopardize participant safety as per investigator opinion, (hemolytic anemia limiting A1c reliability, any evidence of fluid overload, presence of Congestive heart failure etc).

Recent DKA or signs of decompensated diabetes in last 6 months or increased β hydroxybutyrate levels (\>0.4 mmol/L) at screening.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Rochester?

Yes, this clinical trial (NCT06729996) has an active research site in Rochester, MN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Chronic Pancreatitis Treatment Options in Rochester, MN

If you're searching for chronic pancreatitis treatment options in Rochester, MN, this clinical trial (NCT06729996) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Rochester research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced chronic pancreatitis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all chronic pancreatitis clinical trials near you to find additional studies recruiting in your area.

Chronic Pancreatitis Clinical Trial in Rochester, MN

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