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Imaging

Brain Glucose Transport Study for Type 2 Diabetes

N/A
Recruiting
Led By Elizabeth Sanchez Rangel, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
medical history for Type 2 diabetes
Medical history for Type 2 diabetes
Must not have
For women: pregnancy, actively seeking pregnancy, or breastfeeding
Known neurological disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 12
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study how high blood sugar levels affect the brain and if managing diabetes well can reverse these effects. Participants will have several visits and tests to measure glucose levels in the brain and see how

Who is the study for?
This trial is for adults aged 18-60 with Type 2 diabetes who have high blood sugar levels (HbA1c > 7.5%) and a BMI of at least 18 kg/m2. Participants must consent to the study's procedures, be available throughout its duration, and agree to intensify their diabetes management.
What is being tested?
The study uses Magnetic Resonance Spectroscopy Imaging (MRSI) to see if brain glucose transport changes in people with uncontrolled Type 2 diabetes can be reversed by improving blood sugar control over a period of three months.
What are the potential side effects?
While MRSI itself is generally safe and non-invasive, participants may experience discomfort from lying still during the imaging or from wearing the continuous glucose monitor.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a history of Type 2 diabetes.
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I have a history of Type 2 diabetes.
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I am between 18 and 60 years old.
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My HbA1c is above 7.5% and my BMI is 18 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, trying to get pregnant, or breastfeeding.
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I have a diagnosed neurological disorder.
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My high blood pressure is not under control.
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I have a thyroid condition that hasn't been treated.
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I have been diagnosed with cancer.
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I have used steroids in the last 3 months.
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I have a bleeding disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in magnetic resonance spectroscopy (MRS) to assess brain glucose changes

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Brain Glucose Levels in Participants with Type 2 DiabetesExperimental Treatment1 Intervention
Intensification of diabetes management

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,920 Previous Clinical Trials
3,031,449 Total Patients Enrolled
12 Trials studying Diabetes
7,809 Patients Enrolled for Diabetes
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,443 Previous Clinical Trials
4,331,093 Total Patients Enrolled
109 Trials studying Diabetes
138,677 Patients Enrolled for Diabetes
Elizabeth Sanchez Rangel, MDPrincipal InvestigatorYale University
~23 spots leftby May 2027
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