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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Reversibility of Brain Glucose Transport and Metabolism in T2DM

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05776563
• Other study ID #: 2000034676
• Secondary ID: 1K23DK132517-01A
• Status: Recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 31, 2027

Study information

• Verified date: April 2024
• Source: Yale University
• Contact: Elizabeth Sanchez Rangel, MD
• Phone: 203-785-6430
• Email: elizabeth.sanchezrangel[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
United States	Yale New Haven Hospital (YNHH) Research Unit (HRU)	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in magnetic resonance spectroscopy (MRS) to assess brain glucose changes	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