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Imaging

Brain Glucose Levels in Participants with Type 2 Diabetes 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and week 12

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and week 12

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in magnetic resonance spectroscopy (MRS) to assess brain glucose changes

Trial Design

1Treatment groups

Experimental Treatment

Group I: Brain Glucose Levels in Participants with Type 2 DiabetesExperimental Treatment1 Intervention

Intensification of diabetes management

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,853 Previous Clinical Trials

2,738,527 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,314,558 Total Patients Enrolled

Elizabeth Sanchez Rangel, MDPrincipal InvestigatorYale University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals who are older than 35 years eligible to participate in this medical study?

"To be eligible for enrollment in this clinical trial, participants must meet the age criteria of being at least 18 years old but not exceeding 60 years old."

Answered by AI

Are potential participants currently being actively enrolled in this medical study?

"Indeed, the information on clinicaltrials.gov highlights that this research endeavor is actively seeking eligible individuals to participate. The trial was initially listed on 3/1/2024 and most recently revised on 2/2/2024. Enrollment aims to reach a total of 34 participants at one designated site."

Answered by AI

What is the total number of participants being recruited for this clinical investigation?

"Indeed, the details on clinicaltrials.gov indicate that this investigation is presently seeking individuals to participate. This trial was originally posted on March 1st, 2024 and last revised on February 2nd, 2024. Enrollment aims to include 34 patients from a single designated site."

Answered by AI

Which specific criteria must individuals meet to be eligible for enrollment in this research study?

"The clinical trial seeks 34 individuals aged between 18 to 60 diagnosed with type 2 diabetes. Essential requirements include the ability to provide a dated and signed informed consent form, willingness to adhere strictly to study protocols throughout its entirety, having a medical history of type 2 diabetes, HbA1c levels exceeding 7.5%, BMI equal or greater than 18 kg/m², and readiness for intensification of their current diabetes treatment plan."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reversibility of Brain Glucose Transport in Type 2 Diabetes Mellitus (T2DM)

2024. "Reversibility of Brain Glucose Transport in Type 2 Diabetes Mellitus (T2DM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05776563.