NCT03318679

Brief Summary

Hyperglycemia is present in 50 percent of patients with acute ischemic stroke. Patients with hyperglycemia have higher in hospital, 30 and 90 day mortality and morbidity. Sixty percent of these patients have some form of diabetic syndrome, known or unknown. Remaining 40% of patients are not diabetic. Contrary to logic patients with non diabetic hyperglycemia (NDH) have statistically higher morbidity and mortality compared to the diabetic hyperglycemia (DH) cohort. So far multiple treatment trials (THIS, GRASP, GIST-UK, SHINE ongoing) with differing treatment goals have shown no clear benefit, however no obvious distinction was made along the diabetic and non-diabetic hyperglycemic groups. If hyperglycemia in the acute phase was the only culprit in worsening the injury, then there should be no difference in the outcomes for DH and NDH. Existing data implies that the two categories are two distinct physiological entities that are thus not amenable to same treatment. Stating it simply NDH is not an insulin deficient state where as DH is. Alternative possibility is that body and Neurons are accustomed to high sugars in diabetics and thus can tolerate higher sugars better during ischemic stroke compared to non diabetics. The overarching hypothesis is that reducing blood sugars in NDH increases stroke volume and thus consequently worsens outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

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

First Submitted

Initial submission to the registry

September 25, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 24, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2020

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

2.1 years

First QC Date

September 25, 2017

Last Update Submit

March 22, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Difference in the Bio markers of stress between Diabetic and Non diabetic patients that have acute ischemic stroke and hyperglycemia on presentation.

    Lab values

    24 hours

Interventions

None is planned

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Acute Ischemic Stroke Patients that present to University of Minnesota Medical Center and Hennipen County medical Center.

You may qualify if:

  • Patients with acute Ischemic stroke that present to UMMC ER.
  • Age 18-100.
  • Subjects are hyperglycemic (defined as blood sugar above 130mg/dl).

You may not qualify if:

  • Blood sugars less than 130mg/dl.
  • Age less than 18 or more than 100.
  • Difficult blood draw.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • Reshi R, Streib C, Ezzeddine M, Biros M, Miller B, Lakshminarayan K, Anderson D, Ardelt A. Hyperglycemia in acute ischemic stroke: Is it time to re-evaluate our understanding? Med Hypotheses. 2017 Sep;107:78-80. doi: 10.1016/j.mehy.2017.08.017. Epub 2017 Aug 16.

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Ischemic StrokeHyperglycemia

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Rwoof A Reshi, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2017

First Posted

October 24, 2017

Study Start

November 1, 2017

Primary Completion

December 25, 2019

Study Completion

December 25, 2020

Last Updated

March 23, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations