RECRUITING

Reversibility of Brain Glucose Transport in Type 2 Diabetes Mellitus (T2DM)

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

The goal of this clinical trial is to learn about the effects of high blood glucose levels in the brain and assess if the changes seen in individuals with poorly control T2DM can be reversed with good glucose control. The main question\[s\] it aims to answer are: * To determine, whether abnormalities in brain glucose transport seen in individuals with uncontrolled diabetes, can be improved with better glucose control. * Assess which factors, (duration of diabetes mellitus (DM) and glycemic control) contribute to changes in glucose transport Participants will have: * A screening visit * placement of a continuous glucose monitor (CGM) 2 weeks before the first magnetic resonance spectroscopy (MRS) at week 0 * Additional visits/phone calls for intensification of diabetes management and nutrition visits * Second magnetic resonance spectroscopy (MRS) at week 12

Official Title

Reversibility of Brain Glucose Transport and Metabolism in T2DM

Quick Facts

Study Start:2024-07-19
Study Completion:2027-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05776563

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 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form
  2. * Stated willingness to comply with all study procedures and availability for the duration of the study
  3. * Male or female, aged 18-60
  4. * medical history for Type 2 diabetes
  5. * HbA1c \> 7.5%, BMI ≥18 kg/m2
  6. * Be willing to adhere to the intensification of their diabetes regimen
  1. * Creatinine \> 1.5 mg/dL
  2. * Hgb \< 10 mg/dL, hematocrit of 37 % for males participants and 33 % for female participants
  3. * ALT \>3 x ULN
  4. * untreated thyroid disease,
  5. * uncontrolled hypertension
  6. * known neurological disorders
  7. * untreated psychiatric disorders
  8. * malignancy
  9. * bleeding disorders
  10. * current or recent steroid use in last 3 months
  11. * illicit drug use
  12. * for women: pregnancy, actively seeking pregnancy, or breastfeeding
  13. * inability to enter MRI/MRS (as per standard MRI safety guidelines).

Contacts and Locations

Study Contact

Elizabeth Sanchez Rangel, MD
CONTACT
203-785-6430
elizabeth.sanchezrangel@yale.edu

Principal Investigator

Elizabeth Sanchez Rangel, MD
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Yale New Haven Hospital (YNHH) Research Unit (HRU)
New Haven, Connecticut, 06520
United States

Collaborators and Investigators

Sponsor: Yale University

  • Elizabeth Sanchez Rangel, MD, PRINCIPAL_INVESTIGATOR, Yale University

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 Date2024-07-19
Study Completion Date2027-05-31

Study Record Updates

Study Start Date2024-07-19
Study Completion Date2027-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetes Mellitus, Type 2