Reversing brain glucose transport issues in Type 2 diabetes
Reversibility of Brain Glucose Transport and Metabolism in T2DM
This study is testing if better control of blood sugar can help improve how the brain uses glucose in people with poorly managed Type 2 diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT05776563 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of high blood glucose levels on brain glucose transport in individuals with poorly controlled Type 2 diabetes mellitus (T2DM). It aims to determine if improvements in glucose control can reverse the observed abnormalities in brain glucose transport. Participants will undergo a screening visit, receive a continuous glucose monitor (CGM) for two weeks, and have two magnetic resonance spectroscopy (MRS) assessments at the start and after 12 weeks. The study also includes nutrition visits and intensification of diabetes management.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with a medical history of Type 2 diabetes and an HbA1c greater than 7.5%.
Not a fit: Patients with uncontrolled hypertension, known neurological disorders, or those who cannot undergo MRI/MRS may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for brain health in patients with Type 2 diabetes.
How similar studies have performed: Other studies have shown promising results in improving glucose control and its effects on various health aspects, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged 18-60 * medical history for Type 2 diabetes * HbA1c \> 7.5%, BMI ≥18 kg/m2 * Be willing to adhere to the intensification of their diabetes regimen Exclusion Criteria: * Creatinine \> 1.5 mg/dL * Hgb \< 10 mg/dL, hematocrit of 37 % for males participants and 33 % for female participants * ALT \>3 x ULN * untreated thyroid disease, * uncontrolled hypertension * known neurological disorders * untreated psychiatric disorders * malignancy * bleeding disorders * current or recent steroid use in last 3 months * illicit drug use * for women: pregnancy, actively seeking pregnancy, or breastfeeding * inability to enter MRI/MRS (as per standard MRI safety guidelines).
Where this trial is running
New Haven, Connecticut
- Yale New Haven Hospital (YNHH) Research Unit (HRU) — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Elizabeth Sanchez Rangel, MD — Yale University
- Study coordinator: Elizabeth Sanchez Rangel, MD
- Email: elizabeth.sanchezrangel@yale.edu
- Phone: 203-785-6430
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.