RECRUITING

R-5280 in Newly Diagnosed Patients with Type 1 Diabetes

Conditions

Type 1 Diabetes Type 1 Diabetes (Juvenile Onset)Diabetes Mellitus, Type 1

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Evaluating the adverse events and tolerance of R-5280 in Mitigating Type 1 Diabetes in Newly Diagnosed Patients

Official Title

Evaluating the Safety and Tolerability of R-5280 in Mitigating Type 1 Diabetes in Newly Diagnosed Patients

Quick Facts

Study Start:2023-12-05

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06057454

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:11 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* Newly Diagnosed children (age 11-17 years old) * BMI \<85% * Diagnosed by ADA criteria with T1D within 2 years * Accepted to adhere to a healthy diabetic diet as recommended by the ADA	* Monogenic forms of diabetes or type 2 diabetes * History of ongoing infection or antibiotic treatment within the past four (4) weeks * History of immunocompromised, recurrent infections, steroid intake (inhaled or oral forms) or other immunosuppressant use in the past six (6) months * History of chronic gastrointestinal disease, possible or confirmed celiac disease * Pregnancy or possible pregnancy * Allergy to corn (prebiotic), milk allergy, soy (present in the MMTT meal) or their products * Participation in other intervention research trials within the past three (3) months * Anticipated major change in diabetes management during the study (e.g., change from injections to insulin pump therapy or new continuous monitor usage, all known to significantly alter glycemia) * Children consuming a high-fiber or vegetarian diet (consuming three (3) or more servings of high fiber foods on four (4) or more days per week) or any fiber supplements will be excluded (to be assessed at screening) * Any COVID vaccines within 30 days prior to Day 1

Inclusion Criteria

Exclusion Criteria

* Newly Diagnosed children (age 11-17 years old)
* BMI \<85%
* Diagnosed by ADA criteria with T1D within 2 years
* Accepted to adhere to a healthy diabetic diet as recommended by the ADA

* Monogenic forms of diabetes or type 2 diabetes
* History of ongoing infection or antibiotic treatment within the past four (4) weeks
* History of immunocompromised, recurrent infections, steroid intake (inhaled or oral forms) or other immunosuppressant use in the past six (6) months
* History of chronic gastrointestinal disease, possible or confirmed celiac disease
* Pregnancy or possible pregnancy
* Allergy to corn (prebiotic), milk allergy, soy (present in the MMTT meal) or their products
* Participation in other intervention research trials within the past three (3) months
* Anticipated major change in diabetes management during the study (e.g., change from injections to insulin pump therapy or new continuous monitor usage, all known to significantly alter glycemia)
* Children consuming a high-fiber or vegetarian diet (consuming three (3) or more servings of high fiber foods on four (4) or more days per week) or any fiber supplements will be excluded (to be assessed at screening)
* Any COVID vaccines within 30 days prior to Day 1

Contacts and Locations

Study Contact

Janet Stephens, PhD

CONTACT

6504178556

jstephens@risetherapeutics.com

Christian Freguia, PhD

CONTACT

2159231818

cfreguia@risetherapeutics.com

Study Locations (Sites)

Edward Jenner Research Group LLC

Plantation, Florida, 33317

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Spectrum Clinical Research

Kansas City, Missouri, 64118

United States

Collaborators and Investigators

Sponsor: Rise Therapeutics LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-05

Study Completion Date2025-09

Study Record Updates

Study Start Date2023-12-05

Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

Type 1 Diabetes

Additional Relevant MeSH Terms

Type 1 Diabetes
Type 1 Diabetes (Juvenile Onset)
Diabetes Mellitus, Type 1