Recruiting

Observational Study

Sponsor:

Yale University

Code:

NCT05776563

Conditions

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Nutrition visits

Intensification of diabetes regimen

Continuous glucose monitor (CGM)

Study Details

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

Study ID

NCT05776563

Start date

Jul 19, 2024

Status verified date

Jan, 2025

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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 Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Aim 1

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

Interventions

Nutrition visits

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

Intensification of diabetes regimen

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.

Continuous glucose monitor (CGM)

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.

Primary outcome measure

  • Brain glucose concentration in the occipital cortex week 0 [ Time Frame: week 0 ]
  • Brain glucose concentration in the occipital cortex week 12 [ Time Frame: week 12 ]

Central Contacts and Locations

Central contacts

Elizabeth Sanchez Rangel, MD

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

Locations

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

Recruiting

New Haven, Connecticut, United States, 06520

More Information

Sponsor

Yale University

Last update posted

Jan 14, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2025-01-14.