Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
ID05776563

Reversibility of Brain Glucose Transport and Metabolism in Type 2 Diabetes Mellitus

Led by Yale University · Updated on 2025-01-14

24

Participants Needed

1

Research Sites

149 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

N

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how high blood sugar levels affect the brain in people with poorly controlled Type 2 Diabetes Mellitus (T2DM) and whether improving blood sugar control can reverse these changes. The study focuses on understanding if abnormal brain glucose transport in uncontrolled diabetes can improve with better glucose management and which factors like diabetes duration and blood sugar control impact these changes. Participants will undergo a screening visit and use a continuous glucose monitor (CGM) starting two weeks before the first brain scan at week 0. They will attend nutrition visits every two weeks for exercise and dietary counseling and meet with an endocrinologist in person or by phone every two weeks to review and intensify diabetes treatment as needed. A second brain scan will be performed at week 12 to assess changes. During the 12-week study, participants will have their brain glucose levels measured using magnetic resonance spectroscopy (MRS) at the start and end of the study. Researchers will monitor blood glucose levels through the CGM, aiming for specific glucose targets before meals and at bedtime. Regular contact via phone, email, or clinic visits will support maintaining glucose control. Safety and treatment effects will be closely followed throughout the study period.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent form provided
  • Willing to comply with all study procedures and available for the study duration
  • Male or female aged 18-60 years
  • Medical history of Type 2 diabetes
  • HbA1c greater than 7.5%
  • Body mass index (BMI) of 18 kg/m2 or higher
  • Willing to adhere to intensification of diabetes treatment regimen
Not Eligible

You will not qualify if you...

  • Creatinine level greater than 1.5 mg/dL
  • Hemoglobin less than 10 mg/dL or hematocrit below 37% for males and 33% for females
  • Alanine aminotransferase (ALT) more than three times the upper limit of normal
  • Untreated thyroid disease
  • Uncontrolled high blood pressure
  • Known neurological disorders
  • Untreated psychiatric disorders
  • Any malignancy
  • Bleeding disorders
  • Current or recent steroid use within the last 3 months
  • Illicit drug use
  • For women: pregnancy, actively seeking pregnancy, or breastfeeding
  • Unable to safely undergo MRI/MRS according to standard safety guidelines

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Yale New Haven Hospital (YNHH) Research Unit (HRU)

New Haven, Connecticut, United States, 06520

Actively Recruiting

Loading map...

Research Team

E

Elizabeth Sanchez Rangel, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here