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

NCT05776563 | Recruiting

• 2 other identifiers: 20000346761K23DK132517-01A1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Brain glucose concentration in the occipital cortex week 0

  Intracerebral concentrations of glucose across the occipital cortex , as measured by MRS will be compared following hyperglycemic clamp in T2DM individuals at baseline (week0).

  week 0

• Brain glucose concentration in the occipital cortex week 12

  Intracerebral concentrations of glucose across the occipital cortex will be compared between T2DM patients before and after 12 weeks of intensification of their diabetes management.

  week 12

Secondary Outcomes (1)

• CGM metrics

  weeks 12

Study Arms (1)

Aim 1

OTHER

Intervention before and after study with subjects with uncontrolled T2DM to measured brain glucose transport specifically in the occipital lobe during acute hyperglycemia

Behavioral: Nutrition visits; Other: Intensification of diabetes regimen; Other: Continuous glucose monitor (CGM)

Interventions

Nutrition visits BEHAVIORAL

Participants will receive exercise and dietary counseling from a nutritionist and registered dietician with extensive experience with diabetes and obesity every 2 weeks during the 12 wee

Aim 1

Intensification of diabetes regimen OTHER

Patient will meet every 2 weeks in person or have regular phone calls with an endocrinologist to review glucose control and intensification of the diabetes regimens. Will follow the general strategies outlined in the Position Statement of the American Diabetes Association and the European Association for the Study of Diabetes.

Aim 1

Continuous glucose monitor (CGM) OTHER

Individuals with uncontrolled T2DM will be asked use a CGM during the 12 week intervention, to monitor glucose control. Target blood glucose levels will be between 80-130 mg/dl before meals and \< 180 mg/dl at bedtime. Individuals not at goal with glycemic targets will undergo intensification of their regimen. Throughout the study, individuals will be contacted via telephone, email or through additional clinic visits as deemed necessary for maintenance of glycemic control.

Aim 1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Yale University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

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

New Haven, Connecticut, 06520, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Elizabeth Sanchez Rangel, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Sanchez Rangel, MD

CONTACT

203-785-6430; elizabeth.sanchezrangel@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 20, 2023
• Study Start: July 19, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)