NCT04283617

Brief Summary

This study is designed to test if there is a difference in brain glucose transport kinetics in poorly controlled T2DM individuals with short duration and long duration of diabetes, using non-invasive magnetic resonance spectroscopy (MRSI). Also, if these changes are reversible with improved glucose control will be tested. A better understanding of the impact of duration of diabetes on brain glucose transport function may have important implications for understanding the pathophysiology of brain complications in T2DM.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2020

Completed
1.6 years until next milestone

Study Start

First participant enrolled

October 12, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

2.4 years

First QC Date

February 20, 2020

Last Update Submit

February 13, 2024

Conditions

Diabete Type 2

Keywords

continuous glucose monitoring

Outcome Measures

Primary Outcomes (2)

  • Intracerebral concentrations of glucose

    Intracerebral concentrations of glucose across multiple brain locations, including frontal and occipital, as measured by MRSI will be compared following hyperglycemic clamp in uncontrolled T2DM individuals with short duration of diabetes and long duration of diabetes

    Baseline

  • Intracerebral concentrations of glucose between T2DM patients

    Intracerebral concentrations of glucose will be compared between T2DM patients before and after 12 weeks of intensification of their diabetes management

    12 Weeks

Secondary Outcomes (16)

  • Verbal Recognition Memory (VRM)

    Baseline

  • Verbal Recognition Memory (VRM)

    12 Week

  • Paired Associates Learning (PAL)

    Baseline

  • Paired Associates Learning (PAL)

    12 Week

  • Spatial Working Memory (SWM)

    Baseline

  • +11 more secondary outcomes

Study Arms (2)

Diabetic with short duration

EXPERIMENTAL

Type 2 diabetics with HbA1c \> 7.5 % with short duration of diabetes \< 5 years

Behavioral: Intensification of insulin regimen/Nutrition

Diabetic with long duration

EXPERIMENTAL

Type 2 diabetics with HbA1c \> 7.5 % with short duration of diabetes \> 5 years

Behavioral: Intensification of insulin regimen/Nutrition

Interventions

Intensification of insulin regimen/NutritionBEHAVIORAL

The intensification of the diabetes regimens will be managed by Dr. Sanchez Rangel, a fully trained attending endocrinologist, The weight goal will be to have no more than 5% weight change. Participants will have regular phone and in-person MD and nutritionist communication over the course of the 12-week study. All individuals will be asked to perform SMBG at least 4 times a day (before breakfast, lunch, dinner, and bedtime). The daily SMBG records will be sent to Dr. Sanchez Rangel weekly for review to guide adjustment of insulin regimens. Target blood glucose levels will be between 80-130 mg/dl before meals and between \< 180 mg/dl at bedtime. Throughout the study, individuals will be contacted via telephone call, email or through additional clinic visits as deemed necessary for maintenance of glycemic control. All individuals will receive education regarding the detection and proper management of hypoglycemia.

Diabetic with long durationDiabetic with short duration

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Type 2 Diabetics with HbA1c \> 7.5% with short duration of diabetes \<5 years or
  • Type 2 Diabetics with HbA1c \> 7.5% longer duration of diabetes \>5 years

You may not qualify if:

  • Patients treated with incretin-based therapies
  • Creatinine \> 1.5 mg/dL
  • Hgb \< 10 mg/dL
  • ALT \> 3 X ULN
  • Untreated thyroid disease
  • Uncontrolled hypertension
  • Known neurological disorders
  • Untreated psychiatric disorders
  • Malignancy
  • Bleeding disorders
  • Smoking
  • Current or recent steroid use in last 3 months
  • Illicit drug use
  • Women: pregnancy, actively seeking pregnancy, or breastfeeding
  • Inability to enter MRI/MRS (per standard MRI safety guidelines)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2020

First Posted

February 25, 2020

Study Start

October 12, 2021

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

February 16, 2024

Record last verified: 2024-02

Locations

US(1)