No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 60
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
24 (estimated)
Sponsor
Yale University · Other
Who this trial is looking for
This trial is looking for adults with type 2 diabetes to understand how better control of blood sugar affects the brain. Participants will be monitored over 12 weeks to see if improving blood sugar levels can help reverse some brain changes.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with type 2 diabetes
I am aged 18-60
I have an HbA1c level greater than 7.5%
My BMI is 18 kg/m2 or more
I am willing to follow a diabetes management plan
I can provide consent to participate
You may not be able to join if
My creatinine level is over 1.5 mg/dL
My hemoglobin is under 10 mg/dL or hematocrit is too low
I have untreated thyroid disease
I have uncontrolled high blood pressure
I have a neurological disorder
I have untreated psychiatric issues
I am pregnant, breastfeeding, or trying to get pregnant
I cannot safely enter an MRI machine
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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
Trial Locations
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City
State
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Status
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 …
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).
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