NCT05776563 Reversibility of Brain Glucose Transport in Type 2 Diabetes Mellitus (T2DM)
| NCT ID | NCT05776563 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yale University |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-07-19 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2024-07-19 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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).
Contact & Investigator
Elizabeth Sanchez Rangel, MD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT05776563 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05776563 currently recruiting?
Yes, NCT05776563 is actively recruiting participants. Contact the research team at elizabeth.sanchezrangel@yale.edu for enrollment information.
Where is the NCT05776563 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT05776563 clinical trial?
NCT05776563 is sponsored by Yale University. The principal investigator is Elizabeth Sanchez Rangel, MD at Yale University. The trial plans to enroll 24 participants.
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