Is NCT06455319 recruiting in Gainesville, FL?

Yes, NCT06455319 is currently recruiting participants at its Gainesville, FL location. This type 1 diabetes clinical trial is actively enrolling qualified participants.

How do I join the type 1 diabetes clinical trial in Gainesville?

To join this clinical trial in Gainesville, 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 Gainesville 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.

Type 1 Diabetes Clinical Trial in Gainesville, FL

About This Type 1 Diabetes Study in Gainesville

T cell directed therapy, anti-thymocyte globulin (ATG), in low doses, has been shown to lower HbA1c and preserve endogenous insulin production (measured by C-peptide) in individuals with recently diagnosed type 1 diabetes (T1D). However, not all individuals who received ATG responded to the therapy (i.e., non-responders). Additionally, use of ATG alone does not address inherent beta cell stress. A calcium channel blocker, verapamil, has demonstrated C-peptide preservation in newly diagnosed T1D. Investigators will identify those mostly likely to respond to ATG using an ex vivo predictive biomarker of response to ATG. In addition, Investigators will use sequential therapies to increase efficacy (ATG followed by verapamil) and explore synergistic mechanisms. This will be assessing with in depth immunophenotyping and quantify biomarkers of beta cell stress, cell death, and abnormal prohormone processing. Finally, novel clinical trial endpoints will be assessed for their ability to predict treatment efficacy earlier than the standard endpoint at 1 year.

Sponsor: University of Florida

Who Can Participate

Inclusion Criteria

Must be \>= 6 years \<= 35

Must have a diagnosis of T1D for less than 100 days at randomization

Willing to provide Informed Consent or have a parent or legal guardian provide informed consent if the subject is \<18 years of age

Positive for at least one islet cell autoantibody; GAD65A, mIAA, if obtained within 10 days of the onset of insulin therapy, IA-2A, ICA, or ZnT8A

Must have stimulated C-peptide levels of 0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) conducted at least 21 days from diagnosis of diabetes. Randomization should occur within one month (37 days) of the MMTT.

Subjects who are EBV seronegative at screening must be EBV PCR negative within 30 days of randomization and may not have had signs or symptoms of an EBV compatible illness lasting longer than 7 days within 30 days of randomization

Be at least 6 weeks from last live immunization

Participants are required to receive killed influenza vaccination at least 2 weeks prior to randomization when vaccine for the current or upcoming flu season is available

Be willing to forgo live vaccines during the treatment period and for 3 months following last dose of study drug

Be willing to comply with intensive diabetes management

Exclusion Criteria

Be immunodeficient or have clinically significant chronic lymphopenia: (Leukopenia (\< 3,000 leukocytes /μL), neutropenia (\<1,500 neutrophils/μL), lymphopenia (\<800 lymphocytes/μL), or thrombocytopenia (\<100,000 platelets/μL).

Have active signs or symptoms of acute infection at the time of randomization

Have evidence of prior or current tuberculosis infection as assessed by PPD, interferon gamma release assay or by history

Be currently pregnant or lactating, or anticipate getting pregnant within the two year study period

Require use of other immunosuppressive agents including chronic use of systemic steroids

Have evidence of current or past HIV, Hepatitis B or Hepatitis C infection

Have any complicating medical issues or abnormal clinical laboratory results that may interfere with study conduct, or cause increased risk to include pre-existing cardiac disease, COPD, sickle cell disease, neurological, or blood count abnormalities

Have a history of malignancies other than skin

Evidence of liver dysfunction with AST or ALT greater than 3 times the upper limits of normal

Evidence of renal dysfunction with creatinine greater than 1.5 times the upper limit of normal

Vaccination with a live virus within the last 6 weeks

Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control within prior 7 days of screening

Active participation in another T1D treatment study in the previous 30 days

Prior treatment with any investigational agent to delay beta cell loss in T1D

Known allergy to ATG or Verapamil

Prior treatment with ATG, Verapamil or known allergy to rabbit derived products

Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results

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 Gainesville?

Yes, this clinical trial (NCT06455319) has an active research site in Gainesville, FL 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.

Type 1 Diabetes Treatment Options in Gainesville, FL

If you're searching for type 1 diabetes treatment options in Gainesville, FL, this clinical trial (NCT06455319) 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 Gainesville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced type 1 diabetes 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 type 1 diabetes clinical trials near you to find additional studies recruiting in your area.

Type 1 Diabetes Clinical Trial in Gainesville, FL

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