NCT03738852

Brief Summary

To assess if using the hypoglycemic clamp and functional magnetic resonance imaging (fMRI) scanning in hypoglycemia unaware and aware T1DM patients and healthy controls have showed distinct differences in patterns of brain responses. In particular, T1DM patients who are aware of hypoglycemia (T1DM-Aware) have greater activity in sensory integration brain regions (e.g. parietal lobe and caudate nucleus) in response to hypoglycemia, whereas hypoglycemia unaware T1DM patients (T1DM-Unaware) show no detectable changes in brain reward regions during hypoglycemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Nov 2018

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 8, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2023

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

February 12, 2025

Completed
Last Updated

February 12, 2025

Status Verified

January 1, 2025

Enrollment Period

4.8 years

First QC Date

November 8, 2018

Results QC Date

August 12, 2024

Last Update Submit

January 21, 2025

Conditions

Type1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Brain Glucose Levels

    Regional quantification of brain glucose levels with MRS (CMRgl) will be used to measure group differences.

    3 months

Study Arms (3)

Aim 3: Type 1 diabetes mellitus user unaware subjects 3 months

EXPERIMENTAL

Continuous Glucose Monitor for 3 months duration

Device: Continuous Glucose Monitor (CGM)Drug: Insulin

Aim 1: Impact of hypoglycemia on brain connectivity Type 1

EXPERIMENTAL

Healthy controls, T1 aware, and T1 unawares

Drug: Insulin

Aim 2: Impact of hypoglycemia on brain glucose transports in Type 1

EXPERIMENTAL

Healthy controls, T1 aware, and T1 unawares

Drug: Insulin

Interventions

Continuous Glucose Monitor (CGM)DEVICE

Continuous Glucose Monitor (CGM)

Also known as: Dexcom G6
Aim 3: Type 1 diabetes mellitus user unaware subjects 3 months
InsulinDRUG

standard insulin regimen

Aim 1: Impact of hypoglycemia on brain connectivity Type 1Aim 2: Impact of hypoglycemia on brain glucose transports in Type 1Aim 3: Type 1 diabetes mellitus user unaware subjects 3 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages \> 18 years
  • Healthy, non-diabetic control or T1DM
  • BMI \> 18.0

You may not qualify if:

  • Creatinine \> 1.5 mg/dL
  • Hct \< 35% for females, \< 39% for males
  • ALT \> 2.5 X ULN
  • untreated thyroid disease
  • uncontrolled hypertension
  • neurologic disorders
  • untreated depression or change in antidepressant regimen in last 3 months
  • use of any anxiolytic medications (benzodiazepine) or antipsychotic medications
  • greater than 5% change in weight in last 3 months
  • malignancy
  • current or recent steroid use in last 3 months
  • illicit drug use
  • significant complications related to diabetes (peripheral neuropathy, proliferative retinopathy)
  • inability to enter MRI (per standard MRI safety guidelines)
  • for women: pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Center for Clinical Investigation (YCCI) Church Street Research Unit (CSRU)

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

  • Akingbesote ND, Leitner BP, Jovin DG, Desrouleaux R, Owusu D, Zhu W, Li Z, Pollak MN, Perry RJ. Gene and protein expression and metabolic flux analysis reveals metabolic scaling in liver ex vivo and in vivo. Elife. 2023 May 23;12:e78335. doi: 10.7554/eLife.78335.

    PMID: 37219930DERIVED

MeSH Terms

Interventions

Insulin

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Renata Belfort De Aguiar, MD, PhD
Organization
Yale School of Medicine
renata.aguiar@yale.edu
(203) 785-5331

Study Officials

  • Janice Hwang, Hwang

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2018

First Posted

November 13, 2018

Study Start

November 7, 2018

Primary Completion

August 14, 2023

Study Completion

August 14, 2023

Last Updated

February 12, 2025

Results First Posted

February 12, 2025

Record last verified: 2025-01

Locations

US(1)