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

Sponsor
Yale University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05776563
Collaborator
(none)
34
Enrollment
1
Arm
49
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Magnetic Resonance Spectroscopy Imaging (MRSI)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Reversibility of Brain Glucose Transport and Metabolism in T2DM
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
May 31, 2027
Anticipated Study Completion Date :
May 31, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Yale University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT05776563
Other Study ID Numbers:
  • 2000024676
First Posted:
Mar 20, 2023
Last Update Posted:
Mar 20, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Mar 20, 2023