RECRUITING

Denosumab for Type 1 Diabetes

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

Type 1 diabetes (T1D) arises from abnormal immune cell-mediated injury to beta cells that make insulin. The injured beta cells can then no longer make the needed amount of insulin to stay healthy. However, in the early stages of T1D, some beta cells are still alive and functioning. Treatment to protect the beta cells against injury at this time could slow the progress of disease. Denosumab is an approved treatment for osteoporosis (a disease that thins and weakens the bones), high blood calcium levels, bone cancer, and other bone problems in patients who have cancer. The research team has found that the bone pathway that denosumab works on to treat these bone conditions also has effects on the health of the beta cells. Lab studies suggest that denosumab may protect and/or increase the number of beta cells and improve how well they work. This study will test whether denosumab is safe and improves beta cell function and blood sugar control in people with early T1D.

Official Title

A Phase 1/2 Prospective, Randomized, Double-blind, Placebo-controlled Multi-center Clinical Trial to Determine the Safety and Efficacy of Denosumab in Improving Beta Cell Function and Glycemic Control Among Patients With Type 1 Diabetes

Quick Facts

Study Start:2024-09-03
Study Completion:2026-04-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06524960

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:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Arthur Riggs Diabetes & Metabolism Research Institute at City of Hope
CONTACT
1-866-44-ISLET(1-866-444-7538)
Islets@coh.org

Principal Investigator

Fouad Kandeel, MD, PhD
PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Rupangi Vasavada, PhD
PRINCIPAL_INVESTIGATOR
City of Hope Medical Center

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
City of Hope Medical Center
Duarte, California, 91010
United States
Indiana University
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: City of Hope Medical Center

  • Fouad Kandeel, MD, PhD, PRINCIPAL_INVESTIGATOR, City of Hope Medical Center
  • Rupangi Vasavada, PhD, PRINCIPAL_INVESTIGATOR, City of Hope Medical Center

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 Date2024-09-03
Study Completion Date2026-04-11

Study Record Updates

Study Start Date2024-09-03
Study Completion Date2026-04-11

Terms related to this study

Keywords Provided by Researchers

  • Type 1 diabetes, denosumab, HbA1c, beta cell function

Additional Relevant MeSH Terms

  • Type 1 Diabetes