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

April 12, 2024 updated by: Yale University

Reversibility of Brain Glucose Transport and Metabolism in T2DM

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale New Haven Hospital (YNHH) Research Unit (HRU)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Brain Glucose Levels in Participants with Type 2 Diabetes
Intensification of diabetes management
Other: Magnetic Resonance Spectroscopy Imaging (MRSI)
baseline 1HMRSI imaging study, then will undergo intensification of their diabetes management for a period of 12-week and at the end of the intervention they will undergo 1H MRSI scanning to measure intracerebral and plasma glucose levels at euglycemia and following 2 hours of hyperglycemia using the clamp technique (target glucose 220 mg/dl) in the occipital region

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in magnetic resonance spectroscopy (MRS) to assess brain glucose changes
Time Frame: baseline and week 12
Brain glucose changes in the occipital lobe will be measured by 1H MRS following hyperglycemic clamp in T2DM individuals at week 0 and at week 12. An improvement in glucose control indicates an increase in brain glucose levels at week 12 compared to historical control.
baseline and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

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

Investigators

  • Principal Investigator: Elizabeth Sanchez Rangel, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

March 6, 2023

First Submitted That Met QC Criteria

March 8, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000034676
  • 1K23DK132517-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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