NCT05776563Recruiting
Reversibility of Brain Glucose Transport in Type 2 Diabetes Mellitus (T2DM)
Reversibility of Brain Glucose Transport and Metabolism in T2DM
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 6 Mar 2023
- Start date
- 19 Jul 2024
- Primary completion date
- 31 May 2027
- Lead sponsor
- Yale University
- Diseases
- Type 2 diabetes
- NCT number
- NCT05776563
What you commit to
- Study type: Interventional
- Planned participants: 24
- From 19 Jul 2024 to the primary completion date, 31 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- current or recent steroid use in last 3 months
- illicit drug use
Other illness
- untreated thyroid disease,
- uncontrolled hypertension
- known neurological disorders
- untreated psychiatric disorders
- malignancy
- bleeding disorders
Lab values
- Creatinine \> 1.5 mg/dL
- Hgb \< 10 mg/dL, hematocrit of 37 % for males participants and 33 % for female participants
- ALT \>3 x ULN
Other
- for women: pregnancy, actively seeking pregnancy, or breastfeeding
- inability to enter MRI/MRS (as per standard MRI safety guidelines).
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yale New Haven Hospital (YNHH) Research Unit (HRU) Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.