RECRUITING

Regulation of Brain Glucose Metabolism in 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

This is a prospective randomized placebo-controlled double-blind crossover pilot study determining the effect of dichloroacetate on brain function under clamped hypoglycemia in T1DM.

Official Title

Regulation of Brain Glucose Metabolism in Type 1 Diabetes

Quick Facts

Study Start:2025-05-06
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05317455

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 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * a history of severe hypoglycemia and/or hypoglycemia unawareness or
  2. * a history of severe hypoglycemia with a blood glucose \<54 mg/dL, requiring the assistance of another person (with recovery after the administration of oral carbohydrate, intravenous glucose, or glucagon) or
  3. * at least 2 values \<54mg/dl during 2 weeks of CGMS testing during the week prior to study.
  1. * Age \< 18 years or \>55 years.
  2. * Body weight \>85 kg at screening visit
  3. * BMI \> 30 (female) and \>30 (male) kg/m2.
  4. * Untreated proliferative retinopathy
  5. * carriers of glutathione transferase Z1 (GSTZ-1) gene polymorphisms that predispose to DCA accumulation and toxicity

Contacts and Locations

Study Contact

Alice Hahn
CONTACT
4753210504
alice.hahn@yale.edu

Principal Investigator

Raimund Herzog, MD
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Yale-New Haven Hospital
New Haven, Connecticut, 06510
United States

Collaborators and Investigators

Sponsor: Yale University

  • Raimund Herzog, 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 Date2025-05-06
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2025-05-06
Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetes Mellitus, Type 1
  • Hypoglycemia Unawareness